Senior Clinical Data Manager-Oncology - South San Francisco, CA | Biospace
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Senior Clinical Data Manager-Oncology

WeStaffIT, Inc.

Location:
South San Francisco, CA
Posted Date:
5/19/2017
Position Type:
Contract
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

LOCAL CANDIDATES ONLY PLEASE
THIS IS A 6 month (possibly longer if extended) CONTRACT ROLE-W2 OR CORP TO CORP
all work is ONSITE/no remote or telecommute

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.

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
•   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

Requirements

•   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.

LOCAL CANDIDATES ONLY PLEASE
THIS IS A 6 month (possibly longer if extended) CONTRACT ROLE-W2 OR CORP TO CORP