Associate
Director/Director of Data Management, Anti-Infectives/Gastrointestinal
A known branded global pharmaceutical company located
in the Northern New Jersey area is experiencing explosive
growth and seeking an Associate Director/Director of
Data Management, Anti-Infectives/Gastrointestinal. The
incumbent will be responsible for Data Management function
and/or team within the AI/GI area. Responsible for leading
and participating on teams in support of project goals
and objectives. Support Data Management strategy at
local level Manage Senior Managers and provide performance
evaluations. Responsible for protocol review, supervision
of CRF development, and monitoring database design Oversee
data management activities of CRO's or in-house, as
applicable. Participate in development of DM SOPs; assure
effective project management to support company objectives;
assure consistency of data management practices.
Qualifications
Bachelor of Science Degree in associated functional
discipline required. Masters or Ph.D. degree advantageous
8-10 years experience in the CRO and Pharmaceutical
industry required, including line management. Proven
experience leading a data management group and exposure
to multiple therapeutic areas. Advanced knowledge of
I/T infrastructure and extensive knowledge of medical
terminology. In-depth technical expertise in data acquisition,
cleaning, and management techniques Expertise in clinical
study protocols and CRF design. Proven ability to conduct
database testing, clinical data reviews and data clarification
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Senior
Clinical Data Manager, Oncology
A pharmaceutical company located in New Jersey is seeking
a Senior Clinical Data Manager, Oncology to be responsible
for the data management function within Oncology, leading
and participating on teams in support of project goals
and objectives; protocol review, supervise CRF development,
monitor database design, supervise data management activities
of CRO's or in-house, as applicable; responsible for
query generation and resolution process; responsible
for supervising AE and medication coding, SAE reconciliation,
and patient profile review; participate in development
of DM SOP's; supervise direct reports and provide performance
evaluations, as applicable.
Qualifications:
BS Degree /RN required or commensurate experience in
Data Management. Masters degree preferred. CDM certification
a big plus. At least 4 years experience in the pharmaceutical
industry required, including line management. 5 or more
years for the higher level position. Knowledge of Clintrial
or database system. Computer proficiency and understanding
of computer terminology. Knowledge of medical terminology.
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Data Manager III
A pharmaceutical company located in Florida seeks a
Data Manager III to support Product Realization Data
Management activities for all clinical trials, from
Phase I through Phase IV.
Position Summary:
Coordinates all the aspects of Data Management including
the design and ongoing management of all clinical databases
in order to achieve high quality integrated databases,
in a timely manner, to support study teams through a
submission to approval.
Responsibilities:
- Represents Data Management at study and cross-functional
team level.
- Coordinates and manages all aspects of Data Management
for assigned studies (including design, edit checks
and data handling procedures).
- Is responsible for strategies and timelines with regard
to all Data Management activities through to database
lock.
- Plans and prioritizes multiple studies through identifying
resource needs to meet defined timelines.
- Is responsible for creation and maintenance of Data
Management Plan and other Data Management documentation.
- Manages the integration of data from all sources (e.g.
CRFs, central labs, CROs)
- Assists in all aspects of Data Management with respect
to EU and/or US regulatory filings.
- Enables the study team to identify the requirements
of study standards that will facilitate the creation
of an integrated database to support EU and/or US submissions.
- Supports ongoing improvement, standardization and
documentation of Data Management department processes
& procedures.
- Ensures compliance with established SOPs and current
regulatory requirements.
- Manages & assists in mentoring assigned employees
within the Data Management group.
Experience:
- Has worked in a study team.
- Basic understanding of project management.
- Is aware of the submission regulations for US or EU.
- Competent communication & intrapersonal skills.
- Expert with either Clintrial (PLSQL) or Oracle ¿
Clinical
- Understands the Phase II/III development process with
either a Data Manager or Data Coordination background.
- Requires a Bachelor degree and four or more years
of relevant industry experience.
Demands:
- cordial, flexible, and able to interact with peers
and personnel in other departments, reliable.
Level of proficiency:
- must have experience with database development; must
be familiar with a variety of the field's concepts,
practices, and procedures.
Management experience:
- prior experience supervising others is desirable
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