Clinical Data Manager
Proclinical is currently recruiting for a Clinical Data Manager with a pharmaceutical company located in Boston, MA.
- Responsible for vendor oversight activities across global development programs.
- Provides input to functional governance with the strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
- Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Oversees the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
Skills and Requirements:
- BS/BA required preferably in a health-related, life science area and with a minimum of 10 years data management and/or drug development experience.
- Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
- Experience with all phases of development and at least 2 therapeutic areas.
- Ability to handle multiple development programs simultaneously.
- NDA/CTD Experience.
- Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.