Clinical Trial Management Associate

Highly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), Project/Study Manager (CSM/CPM), Clinical Evaluation
  3. United States
San Mateo, USA
Posting date: 16 Sep 2020
This vacancy has now expired

Proclinical is currently recruiting for a Clinical Trial Management Associate with a pharmaceutical company located in San Mateo, CA.

Job Responsibilities:

  • 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.