Clinical Data Manager
Proclinical is currently recruiting for a Clinical Data Manager with a pharmaceutical company located in Boston, MA.
- Serve as lead CDM on assigned clinical trials by attending internal and external clinical trial project team meetings.
- Responsible for the study-specific data management tasks from protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope.
- Responsible for the accurate development of CRFs and edit specification per protocol and the completeness of user acceptance testing of CRFs and associated edit specifications for assigned clinical trials.
- Provide ongoing operational support for Medidata RAVE activities during clinical trial conduct including development of clinical databases and associated external data transfer documents including import/export agreements and data specifications.
- Provide ad-hoc report development, and support database lock and archiving activities.
- Review and contribute as a member of the CRF development team to develop the data collection modules on assigned studies where protocol requirements are outside of standard CRF library versions.
- Ensure that medical coding is completed in a timely fashion, completed for all data cuts, and reviewed and approved by medical monitors.
- Provide guidance to clinical data management personnel on assigned projects, reviewing study documents as needed, e.g. Data Management Plan, Operational Plan for database locks
- Ensure project documentation is being archived in a timely manner into the Trial Master File.
Skills and Requirements:
- Experience in clinical data management for 7+years
- Experience defining, entering, processing, reviewing and validating clinical data; and understanding and following clinical trial protocols and data collection documents.
- Medidata Rave experience required.
- Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.
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.