Manager/Senior
Manager Clinical Research (Contract)
A known branded global pharmaceutical company located
in the Northern New Jersey area is seeking a qualified
candidate for a Manager/Senior Manager who will cover
global Phase II studies with already established shared
coverage in London Office. Responsibilities may include,
but are not limited to reviewing protocols, CRFs and
creating ICFs. Candidate will be global lead for 1global
trial and local lead for another trial. Candidate will
work with CRO to ensure smooth execution of clinical
trial and study start up, including reviewing all study
materials from all participating vendors. May be required
to work with Sr. CRA on planning and executing Investigator
Meetings in 1-3 country regions. Position may also require
oversight and shared monitoring of one to two Phase
1 studies with in-house Sr. CRA
QUALIFICATIONS:
BA/BS minimum, with at least 8 years of clinical research
experience, 4 in the pharmaceutical industry. Clinical
project management experience is required. Cardiovascular
research experience a plus, but not required. Experience
working with CROs is a must.
Approximately 20-50% travel may be required.
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Associate
Director, Clinical Operations, CNS
A known branded global pharmaceutical company located
in the Northern New Jersey area is seeking a qualified
candidate for an Associate Director, Clinical Operations,
CNS role to assume accountability for timely execution
of multiple programs within CNS influence on study teams
within own area of responsibility with technical &
content expertise, lead multiple teams and/or studies
within the Clinical Operations group Actively involved
in committees & improving processes Acts as an informal
mentor & coach to team members
Qualifications:
BS degree in relevant scientific discipline required.
7-10 years broad pharmaceutical industry experience,
including line management experience Sound knowledge
of entire drug development process, including clinical
plan development, study areas & execution of the
entire clinical study chain Knowledge of CNS therapeutic
area preferred Knowledge of FDA/ICH guidelines required,
international preferred Must have strong communication
& leadership skills Must be able to work in a team
environment
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Asscoiate
Director, Clinical Operations, Frontier Associate
A known branded global pharmaceutical company located
in the Northern New Jersey area is seeking a qualified
candidate for an Associate Director, Clinical Operations,
Frontier Associate role to assume accountability for
timely execution of multiple programs within Gastrointestinal,
Anti-Infective and Frontier Significant influence on
study teams within own area of responsibility with technical
& content expertise, lead multiple teams and/or
studies within the Clinical Operations group Actively
involved in committees & improving processes Acts
as an informal mentor & coach to team members
Qualifications:
BS degree in relevant scientific discipline required.
7-10 years broad pharmaceutical industry experience,
including line management experience Sound knowledge
of entire drug development process, including clinical
plan development, study areas & execution of the
entire clinical study chain Knowledge of Gastrointestinal,
Anti-Infective, Rheumatology, Cardiovascular Disease
or Metabolism therapeutic area preferred Knowledge of
FDA/ICH guidelines required, international preferred
Must have strong communication & leadership skills
Must be able to work in a team environment
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Associate
Director, Clinical Operations, Anti-Infectives
A known branded global pharmaceutical company located
in the Northern New Jersey area is seeking a qualified
candidate for an Associate Director, Clinical Operations,
Frontier Associate role to assume accountability for
timely execution of multiple programs within Gastrointestinal,
Anti-Infective and Frontier Significant influence on
study teams within own area of responsibility with technical
& content expertise, lead multiple teams and/or
studies within the Clinical Operations group Actively
involved in committees & improving processes Acts
as an informal mentor & coach to team members
Qualifications:
BS degree in relevant scientific discipline required.
7-10 years broad pharmaceutical industry experience,
including line management experience Sound knowledge
of entire drug development process, including clinical
plan development, study areas & execution of the
entire clinical study chain Knowledge of Gastrointestinal,
Anti-Infective, Rheumatology, Cardiovascular Disease
or Metabolism therapeutic area preferred Knowledge of
FDA/ICH guidelines required, international preferred
Must have strong communication & leadership skills
Must be able to work in a team environment
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Associate
Director, Clinical Operations, Gastrointestinal
A known branded global pharmaceutical company located
in the Northern New Jersey area is seeking a qualified
candidate for an Associate Director, Clinical Operations,
Gastrointestinal role to assume accountability for timely
execution of multiple programs within Gastrointestinal,
Anti-Infective and Frontier Significant influence on
study teams within own area of responsibility with technical
& content expertise, lead multiple teams and/or
studies within the Clinical Operations group Actively
involved in committees & improving processes Acts
as an informal mentor & coach to team members
Qualifications:
BS degree in relevant scientific discipline required.
7-10 years broad pharmaceutical industry experience,
including line management experience Sound knowledge
of entire drug development process, including clinical
plan development, study areas & execution of the
entire clinical study chain Knowledge of Gastrointestinal,
Anti-Infective, Rheumatology, Cardiovascular Disease
or Metabolism therapeutic area preferred Knowledge of
FDA/ICH guidelines required, international preferred
Must have strong communication & leadership skills
Must be able to work in a team environment
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Associate
Director, Clinical Operations
A pharmaceutical company located in New Jersey is seeking
an Associate Director, Clinical Operations to provide
strategic and tactical planning, organization and direction
within Clinical Operations to achieve the completion
of projects on time and within budget. To be responsible
for managing and directing the daily activities of all
Clinical Operations personnel to meet the company objectives.
This includes all monitoring and data management staff.
Directly responsible for planning and implementing all
components of Phase I-IV clinical trials from study
initiation through final integrated
statistical study report. Ensuring Clinical Development
teams have clear goals, objectives and milestones consistent
with corporate objectives. Maintaining effective communication
with senior management so that they are aware at all
times of critical issues confronting the projects and
the action plans that have been put in place to address
those critical issues. Direct the growth and development
of the Clinical Operations department within a small
company environment. Responsible for the hiring, training,
development and management of all staff. Responsible
for the development of departmental policy, SOPs, goals,
and objectives. Direct strategic planning for the department
including the initiation and management of clinical
trials, resource projections, timelines, and departmental
budgets. Establish Clinical Operations infrastructure
including documentation, clinical trial management systems
and clinical database platforms. Directly oversee the
development of all clinical protocols, case report
forms, study reports and all other documentation. Management
of all CRO projects to ensure successful completion.
Ensure that clinical programs are executed in accordance
with the regulatory requirements of the region intended
for submission (i.e., ICH Guidelines and Good Clinical
Practices) and industry standards.
Requirements:
- 10 years of experience in clinical trials including
at least 5 years of management experience.
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Clinical
Trials Manager
A pharmaceutical company that is growing has created
a new position for a Clinical Trials Manager. The Clinical
Trials Manager will be able to organize and facilitate
the overall planning, coordination and general performance
of clinical trials that support the Clinical Development
Plan for Clinical Operations; oversee the initiation
and full execution of clinical trials; and represent
and integrate these activities into the general drug
development stream. These activities include the support
of, and coordination with, contract research organization
personnel (CRO's), consultants, contractors, and other
colleagues in Medical Research Operations, Clinical
Research, Clinical Pharmacology, Medical Affairs, Biostatistics,
Data Management and Regulatory Affairs.
Requirements:
Bachelor's Degree in a scientific field, especially
the medical sciences, along with progress through the
CRA function are required; ability to work with, and
peer-manage, various levels of colleagues involved in
coordinating and executing clinical research; and the
ability to work on a team in a matrix management environment
are essential
The ideal candidate will be familiar with clinical research
methodology, and have adequate medical knowledge to
assist in clinical trial development, and to recognize
medical issues of safety, related to the diseases and
drugs under research; and will have demonstrated expertise
in organizing operational aspects of clinical research.
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Senior
Clinical Study Manager
A pharmaceutical company located in Florida is seeking
a Senior Clinical Study Manager to manage the study
startup, through study report.
Responsibilities:
Manage in the following coordination and oversight of:
·Protocol finalization (including amendments)
·CRF design
·Conducting investigator meetings
·Site selection
·Budget tracking
·Provide training to monitors and investigators
·Document preparation and critical document training
·Strategy: has overall responsibility for program
strategy and oversight of clinical activities across
studies
·Timelines: establishes and ensures study timeline
milestones are met
·Protocol Development: develops protocols, amendments,
consent forms, and authors CSR
·Budget: works closely with finance on overall
budget for project, assist in developing budget forecast,
quarterly accruals, and budget spent and keeps medical
informed.
·Recruitment: responsible for establishing overall
enrollment strategy and forecasts
*Recommendations for problem solving
*Includes strategies for advertising/retention programs
·Study drug: establishes study drug requirements
and timelines for programs with clinical supplies dept.
·Vendors: determines vendor strategy and is involved
in vender selection process
·CRO identification: develop Request for Proposal
(RFP), drive proposal review with study team, determine
CRO selection with team input, negotiate budget and
drive contract negotiation through to execution.
·CRO management: creates CRO communication and
management plans for strong interaction between internal
team and ex-US CRO personnel
·Develops overall data collection plan with Data
Management
·Participate in developing analysis and reporting
plans
·Address high level site related issues with
Study Manager/Supervisor
·Participates in Investigator Meetings and ensure
appropriate training
·Accountable for Clinical master File
·Support regulatory and provide input to IND
safety update, IB update, NDA application
·Attend project team meetings (when requested
by Medical Director), clinical sub-team meetings, and
operations team meetings
Experience:
·Science background MS, MSN, MD or Ph.D. preferred.
·Experience 5-7 years in a pharmaceutical/biotech
(preferred) or CRO
·Study monitoring and/or study coordinating experience
required
·Cardiovascular experience preferred
·Complete understanding of GCPs and Federal Regulations
for conducting clinical trials on drugs
·Computer literacy in Word, Excel, and PowerPoint
·Excellent spoken and written English language
skills
·Excellent interpersonal and organizational skills
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Associate
Director, Clinical Operations
A pharmaceutical company located in Connecticut is seeking
an Associate Director, Clinical Operations, to provide
strategic and tactical planning, organization and direction
within Clinical Operations to achieve the completion
of projects on time and within budget; manage and direct
the daily activities of all Clinical Operations personnel
to meet the Company's objectives, which includes all
monitoring and data management staff; plan and implement
all components of Phase I-IV clinical trials from study
initiation through final integrated statistical study
report; ensure Clinical Development teams have clear
goals, objectives and milestones consistent with corporate
objectives; maintain effective communication with senior
management, so that they are aware at all times of critical
issues confronting the projects and the action plans
that have been put in place to address those critical
issues; direct the growth and development of the Clinical
Operations Department within a small company environment,
including the responsibility for hiring, training, development
and management of all staff; develop Departmental policy,
SOP's, goals and objectives; direct strategic planning
for the Department, including the initiation and management
of clinical trials, resource projections, timelines
and Departmental budgets; establish Clinical Operations
infrastructure, including documentation, clinical trial
management systems and clinical database platforms;
directly oversee the development of all clinical protocols,
case report forms, study reports and all other documentation;
manage all CRO projects to ensure successful completion;
and ensure that clinical programs are executed in accordance
with the regulatory requirements of the region intended
for submission, e.g., ICH Guidelines and Good Clinical
Practices, and industry standards.
Requirements:
Bachelor's Degree in Science related field is required
(Master's Degree preferred), along with 5 to 7 years
of experience in clinical trials, including at least
2 to 3 years of management experience; experience working
in both the Pharmaceutical and Contract Research Organization
environment; excellent communication and presentation
skills; the ability to focus on details, as well as
the broader scope of projects, and to work collaboratively
in a team environment; and experience with MS Project,
MS Office, Word, Excel, PowerPoint, etc.
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Clinical
Supplies Associate
A pharmaceutical company located in Connecticut is seeking
a Clinical Supplies Associate to be responsible for
coordinating all labeling activities for preparation,
approval and shipment of clinical trial supplies. The
Candidate will be responsible for implement and administration
of procedures for initiation, change and approval of
finished pharmaceutical labeling and device labeling.
The Candidate will interact with secondary packaging
vendors to assure proper labeling and distribution of
clinical trial supplies, as well as ensure that assigned
tasks are conducted in accordance with GCP, GMP &
ICH Guidelines.
Requirements:
A BA/BS Degree preferred, with 3 to 5 years of clinical
supplies experience in the pharmaceutical industry,
focusing on clinical packaging and clinical supplies
required. Requires working knowledge of FDA guidelines
and device labeling is preferred. Excellent written
and verbal communication skills and the ability to interact
effectively with Company personnel at all levels is
required. Global labeling, Quality Assurance experience
and Regulatory background and Inventory Management are
a plus. Ability to meet deadlines in a fast-paced environment;
must be proficient with computer programs and have working
knowledge of MS Office Suite; requires teamwork, attention
to detail.
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Clinical
Pharmacology Study Manager
Pharmaceutical company located in Florida is seeking
a Clinical Pharmacology Study Manager to manage the
study planning from startup, execution, and completion
through final report. Encompasses all Clinical Pharmacology
studies.
Responsibilities:
Manage in the following:
- Study design
- CRF design
- Conducting investigator meetings
- Site selection
- Budget tracking
- Monitoring
- Document preparation
- Critical document tracking
- Site interaction
- Represent functional area and provide clinical support
and scientific coordination to project teams.
Experience:
- Science background BS, BSN required; MS, MSN preferred
- Experience 3-5 years in a pharmaceutical/biotech,
hospital research, CRO setting
- Phase I and Phase II study monitoring and/or study
coordinating experience required
- Cardiovascular experience preferred
- Complete understanding of GCPs and Federal Regulations
for conducting clinical trials on drugs
- Computer literacy in Word, Excel, and PowerPoint
- Good spoken and written English language skills
- Good interpersonal and organizational skills
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Senior
Clinical Research Scientist
A pharmaceutical company located in Connecticut is seeking
a Senior Clinical Research Scientist to assist the Clinical
Project Leader in the planning, implementation, managing,
and reporting of clinical trials. May serve as Clinical
Study Team Leader for selected trials. Prepares clinical
trial Synopses and clinical trial Protocols. Prepares
patient SAE narratives, section of the ISS, ISE, Investigator
Brochure, etc. Makes recommendations for the supervision
of monitoring, clinical trial conduct (enrollment, GCP
practices, etc.). Assists in database evaluability assessments.
Prepares or reviews clinical trial reports.
PRINCIPAL ACTIVITIES
Acts as a clinical study team leader responsible for
managing an internal clinical study team with all functional
activities outsourced to a CRO.
Prepares clinical trial synopses and protocols, manages
vendor selection, study site selection, communications,
patient enrollment, compliance, safety, data integrity,
analysis and clinical study reports.
Coordinates preparation and review of clinical trial
databases.
Preparation and review of clinical trial study reports.
Ensures that all assigned studies are conducted according
to GCPs and Department SOPs.
Supports Regulatory Affairs reporting of safety data
and IND annual reports.
REQUIRED EXPERIENCE AND EDUCATION
Requires a Doctoral (PharmD or PhD) level degree (or
in some cases a Masters Degree) with a minimum of 5
years of experience in clinical research in the pharmaceutical
industry. A thorough understanding of clinical research
methodology including study design, protocol writing
and CRF preparation is required as is a knowledge of
GCP and local regulatory requirements. Experience with
the execution and management of all aspects of clinical
trials. Working knowledge of the IND/NDA process acquired
through direct industry experience is required. Knowledge
of medical, scientific and clinical research techniques
in assigned therapeutic area.
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Clinical
Research Scientist
A pharmaceutical company located in Connecticut is seeking
a Clinical Research Scientist to assist the Clinical
Project Leader in the planning, implementation, managing,
and reporting of clinical trials. Contributes in preparing
clinical trial Synopses and clinical trial Protocols.
Drafts patient SAE narratives, section of the ISS, ISE,
Investigator Brochure, etc. May act as, or assist a
clinical study team leader and contribute to the supervision
of study start-up, safety monitoring, clinical trial
conduct (enrollment, GCP practices, etc.) and preparation
of databases for clinical trial reports. These activities
may be outsourced to a CRO, however the CRS would assist
in managing the CRO and monitor there performance of
these study trial activities.
PRINCIPAL ACTIVITIES
Assists the Clinical Study Team Leader in preparation
and review of clinical trial synopses and protocols.
Contributes to the preparation and implementation of
specific training programs for internal and external
staff.
Supports the supervision of monitoring staff to assure
timely enrollment and completion of qualified patients
in clinical trials.
Contributes to the preparation and review of clinical
trial databases.
Assists in the preparation and review of clinical
trial study reports.
Ensures that all assigned studies are conducted according
to GCPs and Department SOPs.
REQUIRED EXPERIENCE AND EDUCATION
Requires a Doctoral (PharmD or PhD) level degree (or
in some cases a Masters Degree in a related discipline)
with a minimum of 1-3 years of clinical research experience,
preferably within the pharmaceutical industry. A thorough
understanding of clinical research methodology including
study design, protocol writing and CRF preparation.
A knowledge of the IND/NDA process is preferred.
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Senior Clinical Research Associate
Responsible for management of clinical trials, both
directly and working with contracted organizations (eg
CROs). This position focuses on coordination of all
activities required to initiate, monitor and complete
clinical programs. In addition, this person will oversee
and act as mentor for less senior members of the Clinical
Trial Team.
Job Duties and Responsibilities
Coordinate and manage off-site contract needs for clinical
projects including monitoring, data management, and
central laboratories.
Act as Protocol Lead on one or more projects
May function as primary contact for CROs to insure their
performance to the terms of contract, GCP/ICH adherence,
and overall quality of work.
Coordinates day-to-day activities of CRO management
of clinical studies including flow of documents and
information to and from sites and/or external vendors
Facilitate the flow of information between contract
CRAs, CROs and in-house team members and other involved
members of the department and cti.
Oversee drug accountability system, including calculation
of drug needs, drug ordering process and management
of drug accountability for overall project.
Provide support to other CRAs and assist in the initiating,
monitoring and coordinating day-to-day operations of
investigational study sites as needed.
Participate in the design of clinical studies in collaboration
with senior management, medical monitor, biostatistician,
and regulatory affairs.
Participate in the review of clinical protocolsParticipate
in the creation and tracking of detailed project plans
including budgets and timelines for clinical projects.
Participate in the evaluation, training and refining
of departmental SOPs and guidelines, and the development
of standard reports, templates and forms
Coordinate and or prepare of clinical documents such
as protocols, case report forms and informed consent
forms.
Problem-solve clinical study and related personnel issues.
Identify, evaluate and select clinical investigators
and investigative sites.
Assist in the negotiation of clinical investigator budgets.
Collaborate with Manufacturing Operations to coordinate
drug supply and for drug labeling, packaging and distribution.
Train and mentor clinical research associates in study
management and GCP.
Manage internal (dotted line or functional) and external
CRAs, and other external vendors as necessary.
May monitor clinical studies for protocol compliance
and GCP/ICH adherence as outlined below:
Problem-solve specific clinical site issues.
Maintain detailed site and patient information for assigned
sites via CTI electronic clinical trial management system
Perform the following routine monitoring functions;
Source document review and comparison to CRF data
CRF review/retrieval and data corrections
Drug accountability
Maintenance of on-site investigator files
Review of IRB documentation
Review local laboratory documentation
Maintenance of investigational supplies
Reviews consent process for each subject (Informed Consent
Form and source documentation)
Handling of safety and efficacy issues, including, but
not limited to:
Review and management of Serious adverse event reports
Conducts monitoring visits and site contact, including:
Prestudy visits
Initiation visits
Monitoring visits
Telephone contacts
Study completion visits
Experience & Educational Background
8+ years Clinical Research experience or equivalent,
experience in the
Pharmaceutical Industry is highly preferred
Bachelors in scientific discipline, RN or health care
professional or equivalent.
An advanced degree is a plusExperience managing CRO
relationships desired.
Oncology and Hematology Clinical Research experience
preferred
Past experience working in both a CRO and sponsor a
plus
Knowledge, Skills and Abilities
Ability and willingness to travel is required (domestic
and internationally)
Thorough knowledge of FDA and ICH requirements
Understand clinical drug development process
Proficient in development of clinical tools and documents
Excellent communication skills
Excellent organizational skills required
Excellent Clinical monitoring skills
Ability to Plan, organize and conduct clinical studies
with minimum oversight
Thorough knowledge of RECIST response criteria and CTC
Adverse Event
Grading
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Clinical Supplies Manager
A global progressive pharmaceutical company in New
Jersey seeks a Clinical Supplies Manager to oversee
the coordination and track drug shipments to and from
investigational sites. Manage the database with drug
shipments by study/site. Follow up with investigational
sites and distribution facilities on shipping discrepancies.
Monitor inventory of packaged supplies
Candidate must have BA/BS degree with 5 years clinical
supplies experience. Excellent communication and organizational
skills. Exceptional attention to detail
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Senior CRA, Oncology
Pharmaceutical company located in New Jersey seeks
a Senior CRA, Oncology. Responsibilities will include:
Plan & direct daily clinical project management
activities for Phase I-III oncology studies including
the coordination of re-sourcing, training, time &
budget management & execute clinical development
plans.
Supervise/mentor team consisting of Senior/Clinical
Research Associate(s), consultant(s) and/or administrative
assistant(s).
Manage CRO activities for Phase I-III oncology studies
including coordination of Kick-Off meetings, study site
initiation meetings, co-monitoring, investigator/site
personnel interactions to ensure compliance with appropriate
FDA guidelines, standard operating procedures, good
clinical practices and all local, state and federal
regulations.
Serve, as needed, on projects deemed necessary by the
Senior Manager, Clinical Operations - Oncology.
Prepare and/or review site/CRO, vendor contracts, requests
for proposals, CRF's and completion guidelines, protocols,
reports, CDP's, site/CRO/vendor budgets, critical study
documents, charts/tables & data.
Recruit, recommend investigators/sites.
Interview, evaluate & select prospective vendors
or service providers required for outsourcing, including
site monitoring & site management of oncology trials.
A BS degree is required - in science or nursing preferred.
3+ years experience in oncology including monitoring
and/or project management CRO experience preferred (either
direct or indirect). Lotus Notes, Word, Excel, PowerPoint,
Microsoft Project and internet experience required.
Ability to travel both domestically and internationally.
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Associate Director, Clinical Operations (anti-infective)
Pharmaceutical company located in New Jersey is seeking
an Associate Director Clinical Operations (Oncology).
Responsibilities will include:
Ensure that the Oncology therapeutic area of Clinical
Operations is adequately resourced and trained to meet
the company's short and long-term goals with respect
to monitoring/management of its clinical trials.
Directly supervise Oncology Clinical Operations strategies.
Responsible for delivery of Oncology project milestones
on time.
Coordinate the collection and review of key monitoring
processes to be benchmarked, tracked, analyzed and improved
upon with respect to monitoring activities, gathering
information and scheduling presentations by monitoring
CRO's and facilitating the bidding process and contracting
activities.
Significant influence on study teams within Oncology.
Sound knowledge of entire drug development process,
including clinical plan development, study areas and
execution of the entire clinical study chain; Must know
Code of Federal Regulations (CFR), ICH guidelines, project
management, data management, corporate/regional SOPs;
Strong computer skills (Word, Excel, PowerPoint); Demonstrated
ability to manage and coach reports who are managers
and individual contributors.
A BS degree in a relevant scientific discipline required,
MD or PhD highly preferred
7-10 years broad pharmaceutical experience, including
line management experience also required.
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Manager, Clinical Operations - Oncology
Pharmaceutical company located in New Jersey seeks a
Manager, Clinical Operations CNS. Responsible for supporting
Phase I & II studies of a specific project.
A track record of successful completion of studies
within timelines & budget;
CNSbackground and/or Phase I experience a plus. Experience
within in managing direct reports preferred. Excellent
communication skills.
BS degree in scientific discipline required, MS degree,
or higher, in relevant scientific discipline preferred.
5+ years experience in the pharmaceutical industry,
with multiple study experience in relevant therapeutic
areas.
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Senior Clinical Research Associate - Anti- Infective
Senior Clinical Research Associate Anti-Infective
Clinical Operations
Northern NJ
A progressive, expanding global pharmaceutical company
seeks a Senior Clinical Research Associate to work on
an anti-infective trial and assist in the management
of a Global sites and patient trials. Work autonomously
with strong organizational, prioritization and analytical
skills. Effectively manage time to meet project deliverables
and deadlines in a manner that minimizes rework.
Act as individual contributor in team meetings.
Candidates must have a BS/BA in a relevant scientific
discipline with 1-5 years experience. Should have basic
understanding of clinical study processes, with specialized
technical skills to deliver own work within the clinical
study team.
Experience monitoring a large trial is a plus. There
is minimal travel.
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Senior Manager Clinical Research - Anti- Infective
Senior Manager Clinical Research Anti-Infective
Clinical Operations
Northern NJ
A progressive, expanding global pharmaceutical company
seeks a Senior Clinical Research Associate to work on
an anti-infective trial and assist in the management
of a Global, 200 sites, 3000 patient trial. Went autonomously
with strong organizational, prioritization and analytical
skills. Effectively manage time to meet project deliverables
and deadlines in a manner that minimizes rework.
Act as individual contributor in team meetings. Sound
knowledge of a number of areas in the drug development
process, including clinical plan development, study
areas and execution of the clinical study chain together
with in-depth knowledge of the therapeutic area.
Candidates must have a MS/BS/BA in a relevant scientific
discipline with 5 years experience. Should have basic
understanding of clinical study processes, with specialized
technical skills to deliver own work within the clinical
study team.
Experience monitoring a large trial is a plus. There
is minimal travel.
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Clinical Quality Assurance Auditor II
Position Summary:
Perform central study file audits, routine clinical
study site audits, and other clincally related audits
(documents or department) as required in compliance
with Standard Operating Procedures (SOPs), guidelines,
the Code of Federal Regulations (CFR), and other related
documents within specified timelines.
Responsibilities:
- Assists in the development of audit tools and plans.
- Performs central study file and site-specific study
file audits for compliance with SOPs, guidelines, the
CFR, and other related documents.
- Performs routine investigational site and or system
audits for compliance with SOPs, guidelines, the CFR,
and other related documents.
- Generates an audit report and participates in follow-up
until resolution.
- Reviews final clinical study reports and clinical
documents (e.g., MedWatch forms) for accuracy.
- Reviews protocols, sample CRFs, and other related
documents for accuracy.
- Participates in the development and review of departmental
SOPs.
- Assists in the review of SOPs and assists in the maintenance
of the SOP distribution system for SOPs generated in
Product Realization, Lead Optimization, and Compliance
departments (excluding Clinical Supply department).
- Assists in implementation of electronic document management
system for SOPs, including electronic signatures and
training.
- Enhances knowledge by review of literature, guidelines,
and CFR.
- Communicates verbally and/or in writing issues or
trends found upon auditing.
Experience: Education: Associates/Bachelors degree
in nursing preferred, or AA/BS in one of the sciences
or related fields,
plus at least 3 years pharmaceutical industry experience
in investigational site auditing or clinical quality
assurance.
General: Excellent organizational skills, good verbal
and written communication skills, professional attitude,
cordial, adaptable, good interpersonal skills, reliable,
detail- and deadline-oriented, efficient, good problem-solving
skills, able to work independently, good decision-making
skills, takes initiative with new projects, able to
perform multiple tasks simultaneously, good leadership
skills.
Regulatory: Working knowledge of FDA regulations including
ICH and GCPs.
Analytical: Able to be successful in identifying issues,
securing relevant information, identifying relationships,
and making decisions based upon logical assumptions
and factual information.
Computer: Microsoft Word, Outlook, Windows, Excel. Able
to learn document-management systems (e.g., tracking,
scanning, and query systems).
Demands: Regular working hours. Flexibility and availability
to respond to business needs as they occur, regardless
of business hours is vital. Occasional travel (25 to
35%) to investigational site audits is required
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Project Manager Clinical Operations
Pharmaceutical company located in New Jersey seeks
a Project Manager. The Project Manager is responsible
for overseeing the multidisciplinary project teams to
assure accurate and timely completion of all technical
and clinical functions required by the study protocol.
Guides, directs, supervises, trains and mentors project
staff to facilitate study success.
Responsible for conducting clinical studies in accordance
with GCP, SOPs, FDA and ICH Guidelines.Drives quality,
and cost for assigned clinical trials.
Designs, communicates and implements project plans.
Establishes scope of work, priorities, timelines and
processes for project team.
Ensures integrity of clinical trial data through leading
the project teams, training, data review, process improvement
and team facilitation.
Tracks and understands study progress, out of scope
work, budget compliance, and project team responsibilities.
Represents the company at Investigator Meetings.
Reviews the imaging requirements of each study and develops
protocol initiation plans including charters, oversees
implementation of clinical studies, analyzes and interprets
clinical results, and prepares clinical progress reports
and summaries for sponsors as requested.
In collaboration with the Manager, Clinical Operations
defines the project team and required resources.
Develops, reviews, revises and evaluates SOPs, study
specific procedures, and databases used to manage assigned
clinical trials.
Identifies training needs/learning opportunities and
participates in the training and educating of the company's
project teams and external customers (physicians, investigators,
study coordinators, CROs, sponsors, etc.). Responsible
for his/her own professional development.
Frequent liaisons with sponsor, contract research organizations
(CRO) and investigator sites staff. Participates in
sponsor site visits and audits as requested.
Anticipates and identifies issues, and contacts the
appropriate site and/or sponsor for issue resolution.
Ensures confidentiality of study protocols and subjects
is maintained.
Ensures security of all radiographic images, and study
and regulatory documents.
Communicates effectively, verbally and in writing, with
all internal and external customers (physicians, investigators,
study coordinators, CROs, sponsors, coworkers, etc.)
Reports study needs and issues to the Chief Operating
Officer.
Resolves technical/radiological/study concerns and problems
in collaboration with others.
Performs quality assurance on raw data, reports, CRFs,
and other required regulatory documents.
Participates in various performance improvement processes.
Maintains a safe work environment. Reports workplace
hazards immediately.
A College/University degree with experience in research
and/or imaging core lab; organization and time management
skills to manage multiple projects simultaneously. Self
motivated, flexible and adaptable to business needs.
Outgoing, friendly, professional.
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Contract SOP Writer
A well known global pharmaceutical company in northern
New Jersey is looking to augment their team with a SOP
Writer. Author, develop and maintain documents. Must
have Clinical Trial and GCP experience. This person
will be in charge of overseeing the development, revision,
approval and distribution clinical SOPs. The SOP writer
will lead and facilitate document lifecycle review with
the local & global Working Groups. They will coordinate
the periodic review cycle and create/oversee the creation
of training materials.
The ideal candidate for this opportunity will have
3 or more years related pharmaceutical industry experience
with Clinical trials and GCP regulations. They must
demonstrate excellence in oral and written English communication.
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Manager/Senior Manager, Clinical Operations, CNS
Job Description
A well known branded pharmaceutical company in New Jersey
seeks Clinical Operations professional who possess technical
(and possibly management) capabilities to lead large
or multiple clinical studies from protocol development
to final analysis and submission within a therapeutic
or compound area
Knowledge of a number of areas in the drug development
process, including clinical plan development, study
areas and execution of the clinical study chain and
of the therapeutic area
Manages multiple resources within and across clinical
operations groups to meet deliverables Leads and facilitates
team meetings by providing guidance to team members
by structuring approaches and adding insight to facilitate
task execution
Qualifications
Bachelors of Science degree in a relevant scientific
discipline
5+ years experience in pharmaceutical industry, including
managing outsourcing to CROs. Line management experience
highly preferred
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Clinical Research Associate CNS
Job Description
A well known branded pharmaceutical company in New
Jersey seeks CRA to carry out assigned administrative
and technical work tasks and activities within a clinical
study team
Assumes accountability for individual role responsibilities
as articulated by supervisor
Effectively manages time to meet project deliverables
and deadlines in a manner that minimizes rework
Takes appropriate care to ensure quality of data. Keeps
informed and up-to-date on information directly related
to own position in the clinical operations study team
Qualifications
Bachelor's degree in relevant scientific discipline
required
1-2 years experience required
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Clinical Supplies Coordinator
Clinical Supplies Coordinator
A global progressive pharmaceutical company in New Jersey
seeks a Clinical Supplies Coordinator to coordinate
and track drug shipments to and from investigational
sites. Maintain and update Excel database with drug
shipments by study/site. Follow up with investigational
sites and distribution facilities on shipping discrepancies.
Monitor inventory of packaged supplies Provide administrative
support to Manager(s)/Associate Director which entails
copying, faxing, setting up meetings, processing invoices,
etc.
Candidate must have BA/BS degree with 1-2 years clinical
supplies experience. Excellent communication and organizational
skills. Exceptional attention to detail. Must be proficient
in Microsoft Word/Excel
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Clinical Project Coordinator
A progressive, expanding global pharmaceutical company
seeks a Clinical Project Coordinator.
Description:
Manage operational aspects of Phase 1 Clinical trial
Conduct pre-study, initiation, interim and close-out
site visits
Assist in development, review and approval of protocol,
Case Record Forms, and other study documents
Review and process regulatory documentation from study
site
Qualifications:
Minimum of two years monitoring experience required
Experience with Phase 1 cardiology trials preferred
Knowledge of CNS therapeutic area a plus
Knowledge of FDA/ICH guidelines
Strong written and verbal skills
Ability to work in a team environment
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Associate Director Data Management - CNS
A well known branded global pharmaceutical company in
New Jersey seeks an Associate Director Data Management
to direct all phases of clinical data management for
the CNS Therapeutic Area. Oversee in-sourced and out-sourced
clinical data management processes and activities. Oversee
coding process and contribute to CRO identification,
selection, SOW, review CRO contracts and oversee management
of CRO data management activities/deliverables. Oversee
management of multiple clinical projects. Interface
with Project Management to contribute to current study
timeline reports. Oversee database lock and review process.
Supervise and provide guidance to direct reports. Oversee
CRF development process, database development activities,
data management activities of co-promote projects. Protocol
review and contribute to the SOP development and review
process, manage contracts and documents/forms. Contribute
to the development process.
Qualifications
MS degree or higher in a scientific or health-related
field
Minimum 8 years pharmaceutical industry experience or
CRO, with at least 8 years in clinical data management,
including extensive experience working with CRO's contracts,
scopes of work, SOPs
Minimum 5 years' supervisor experience
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