ABOUT THE COMPANY
Clinical Solutions Group (CSG) specializes in providing contract and permanent staffing services to the pharmaceutical industry. Our employees enjoy outstanding salaries, group health/dental insurance, vision, life insurance, short/long-term disability, 401K, paid time off, performance bonuses, training reimbursement, and relocation. We welcome you to see why CSG is considered to be one of the premiere providers by visiting our web site at www.csg-inc.com.
position description
Project Manager Data Manager
Mid sized pharmaceutical company in Bridgewater area has an immediate need for an experienced Data Manager. Details are as follows:
General Summary:
Contribute to data management activities related to drug product development for assigned compounds or indications. Collaborate with internal biostatistics, Clinical Operations, and CRO data management and biostatistics.
Essential Duties & Responsibilities:
1. Lead efforts for eCRF design with Biostatistics and Clinical Operations and coordinate a final CRF, edit checks, data review and data extracts.
2. Review published CRFs and hyperlinks in support of FDA, EMEA or worldwide submissions
3. Review data definition files and other DM or biostatistical components of a submission to ensure content meets Regulatory agency submission requirements
4. Review CRF for consistency with Company standards
Essential Knowledge, Skills, & Experience:
1. B.S. required. Preference in science or computers
2. 6-8 years of data management experience with
3 years in a project lead capacity
3. Must have at least 2 years of Oncology data management experience
4. Strong project management experience within data management
5. Proven ability to manage multiple vendors on a given study (i.e., CROs, EDC, Lab vendors)
6. The ability to interface with Medical Writing, Clinical, Statistics, and Drug Safety
7. Must attend and/or present at investigator meetings on behalf of Company Systems
8. Excellent communication and writing skills
9. Knowledge of FDA, EMEA and ICH guidelines and regulations covering clinical trials, statistics, and data management preferred
10. Knowledge of EDC and CDISC preferred
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