Clinical Data Manager (Contractor)
The Clinical Data Manager Contractor is responsible for cleaning data on various oncology studies, reviewing output of reports for compliance with 21 CFR part 11, and following up with sites to ensure prompt response to queries and the entry of expected data.
Principal Duties and Responsibilities:
- Review data and generate queries according to the data validation plan (DVP)
- Employ critical thinking to find inconsistencies in patient data
- Interface with site personnel, monitors and clinical operations staff to expedite the resolution of queries and to ensure sites are up to date with data entry
- Review output of listings, tables, and figures and compare to EDC data to ensure the completeness and correctness of reported data
- File trial documents in the Trial Master File
- Perform tasks according to company standard operating procedures (SOPs) and in accordance with GCP
- Bachelor’s degree or equivalent experience
- Minimum of five years of direct clinical data management experience in the biotechnology or pharmaceutical industry, preferably with oncology study experience
- Working knowledge of Good Clinical Practices and ICH guidelines related to CDM
- Effective written communication skills
- In office 40 hours per week for approximately 6 months
Rate commensurate with experience and qualifications.
NOTE: This description is not intended to be all inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job which may include other duties as assumed or assigned