THIS ROLE IS CONTRACT, EITHER W2 OR C2C
NO REMOTE OR TELECOMMUTE. ALL WORK IS ONSITE AT CLIENT’S OFFICES IN EITHER SOUTH SAN FRANCISCO OR WEST LA
Our Biotechnology client has an immediate need for a Clinical Data Manager on a long term contract basis to lead studies in Oncology areas. You will be responsible for coordination of CRF design, development, review and sign off ; Reviews and approves CRO generated Data Management documents, coordinates database live and close out activities with the CRO, provides guidance to CRO to manage query flow and implements quality control plan. The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed; may participate in vendor qualification and selection as appropriate, and participates in monitoring vendor performance.
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
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
Assist with the training of new employees and/or contractors
BA/BS, preferably in the scientific/healthcare field.
At least five – seven years experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, 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.
Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies.