Clinical Trial Management Associate
Proclinical is currently recruiting for a Clinical Trial Management Associate with a pharmaceutical company located in San Mateo, CA.
- Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
- Provide support and guidance, as required, to Affiliate Clin Ops & Medical Affairs personnel responsible for managing CO and ISR studies.
- Maintains a good understanding of industry standards for CO and ISR studies and keeps abreast of any new changes and developments which could impact Late Phase research operations.
- Assist the CTM to organize and lead review/approval meetings for CO proposal.
- Prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions.
- Able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions.
- Participate in or manage project meetings and conference calls with CROs, vendors, and multi-functional teams.
- Able to anticipate obstacles and proactively develop solutions to achieve project goals.
- Develop a general understanding of functional issues and routine project goals from an organizational perspective.
- Participate in abstract presentations, oral presentations, and manuscript development activities
- Interact and cooperate with individuals in other functional areas to address routine study issues.
- Develop tools and processes that increase measured efficiencies of the project.
- Assist in trainings for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs)
- For GS studies, assist in selecting Contract Research Organizations (CROs) or vendors.
- Assist with the setting and updating of study timelines.
- Participate in departmental, or interdepartmental, strategic initiatives under general supervision.
- Assist in review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
- Conduct site evaluation, initiation, co-monitoring, and closeout visits, in addition to the routine monitoring visits.
- Ensure that the site complies with the protocol and regulatory requirements for GS studies.
- For GS studies, draft and coordinate review of protocols, informed consents, case report forms, and monitoring plans.
- Travel may be required
Skills and Requirements:
- Bachelors or Masters degree with 4+ years of experience in clinical trials/operations, vendor management experience, and clinical site startup and closeouts.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
- Working knowledge and experience with Word, PowerPoint and Excel.
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.