Senior Clinical Data Manager with Oncology experience

Senior Clinical Data Manager with Oncology experience

Job Code: TJ_8698
Job Location: San Francisco, California
Zip Code: 94101
Job Category/Title:
Employment Category: Contract - Corp-to-Corp, Contract - Independent, Contract - W2
Position Type: Senior Level
Travel Required: No
Interview Type: In-person
Education: Bachelors Degree
Experience: 5-10 year(s)
Job Description: Skills Required:

. BA/BS with at least six years' experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment.
. Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform some of the core Data Management tasks and interact with vendors.
. Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, Med DRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
. Experience and understanding of the Oncology therapeutic area, and with Phase III pivotal studies are desirable.
. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.


Responsibilities:

. Able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
. Able to support several clinical studies with minimal guidance.
. Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies.
. Review protocols for appropriate data capture. Able to perform a thoroughly detailed review of data requirements.
. Interact with CRAs, programmers, study managers and statisticians.
. Develop data edit check specifications and run data listings as required.
. Develop the Data Management Plan for a clinical study.
. Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.
. Enter data queries into the system to be resolved at investigational sites and manage the resolution of those queries.
. Perform reconciliation of header data from external data sources against the clinical database.
. Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines.
. Assist in database upgrades/migrations including performing User Acceptance Testing.
. Able to maintain study workbooks and data management files.
. Perform database lock and freeze activities per company SOPs.
. Participate in regular team meetings and provide input when appropriate.
. Provide input into the development of data management SOPs, Work Instructions, and process documents.
Duration: 12 Month(s)
No. of Posts: 1
Job Expiry Date: November 25, 2016
Telecommute: No
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