Title: High Level Clinical Data Management Consultant
Type: W2 Contract (6-12+ Months)
A smaller biotechnology company that is focused on developing therapeutics for cancer patients with both hematology and solid tumor oncology is currently looking for a high level consultant within clinical data management. This candidate will oversee the the start-up and execution of several trials with a CRO or in-house to ensure data quality and integrity. The individual will perform a variety of complex and exciting tasks while overseeing several clinical trials and coordinating cross functionally with the other biometrics teams.
- 10+ years CDM experience
- Must have experience managing direct reports
- Must have 3+ years Oncology (Solid Tumor and Hematology is preferred)
- Must have previous medical coding experience (MedDRA and WHODrug)
- MUST have pervious CRO oversight experience
- Must have experience reporting into ClinOps/Working closely with ClinOps
- MUST have pharma experience, not just CRO
- MUST be able to work independently
- More oversight, less hands on role - will still do some hands on data management
- Know how DM and stats works/work together, structures of DM, regulatory requirements, CDISC, RAVE, EDC- review of DM to ensure study data protection
- Communication skills a must because they must transparently communicate study data and status to CROs
- Bachelor's degree or above in related field
If you are interested in this position, please do not hesitate to apply!!!