For The Candidates

( 908) Area code                                                                       Northern , NJ

 

Clinical Data Manager

 

 

Job Summary : 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 our Co.  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 the company
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