Associate Clinical Trial Manager
Proclinical is currently recruiting for an Associate Clinical Trial Manager with a pharmaceutical company located in San Mateo, CA. A successful candidate will have experience with clinical operations and vendor management.
- Assures site compliance with the routine protocol and regulatory requirements and quality of data.
- Assists in the setting and updating of study timelines.
- Assists in CRO or vendor selection.
- With guidance from supervisor coordinates CROs or vendors.
- Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
- Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
- Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
- May participate in abstract presentations, oral presentations and manuscript development.
- Interfaces with individuals in other functional areas to address routine study issues.
- May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
Skills and Requirements:
- Travel is required.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Working knowledge and experience with Word, PowerPoint and Excel.
- Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.
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.