Clinical Data Manager
Proclinical is currently recruiting for a Clinical Data Manager with a pharmaceutical company located in Philadelphia, PA.
- Serve as lead CDM on assigned clinical trials
- 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
- 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
- Ensure that medical coding is completed in a timely fashion, completed for all data cuts, and reviewed and approved by medical monitors.
- Participate in the development of standard operating procedures (SOPs).
- Mentor junior staff on clinical data management activities and procedures.
- 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:
- Bachelor's Degree and 7+ years of relevant experience
- Knowledge of Microsoft Office and Medidata RAVE
- Vendor management skills
- Experience with CDASH terminology and/or MedDRA and WhoDrug coding
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.