Clinical Data Project Manager
Proclinical is currently recruiting for a Clinical Data Project Manager with a pharmaceutical company located in Cambridge, MA.
- Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and sponsor for all data related deliverables, especially in support of key decision points and regulatory submissions.
- 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.
- Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc.
- Participates and represents function in formal inspections and audits as requested.
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.
- Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Proven track record of strong project management skills
- Experience with all phases of development and at least 2 therapeutic areas
If you are having difficulty in applying or if you have any questions, please contact Brianna 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.