Clinical Trial Management Associate

Highly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), Project/Study Manager (CSM/CPM), Program Manager / Director
  3. United States
San Mateo, USA
Posting date: 28 Aug 2020
CR.CN.31487

Proclinical is currently recruiting for a Clinical Trial Management Associate with a leading pharmaceutical company located in San Mateo, CA. As the Clinical Trial Management Associate, you will have at least 4 years of experience within Clin Ops/Clinical Trials. CRC/CRA background highly preferred.

Job Responsibilities:

  • Acts as primary contact for study drug planning and shipping with Materials & Logistics.
  • Forecasts, tracks, and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.
  • Provides monthly study updates to the appropriate internal stakeholders.
  • Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.
  • Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
  • In collaboration with the Clinical Program Manager (CPM), provides training for new hires, as applicable.
  • Organizes and leads review/approval meetings for CO proposal.
  • Actively participates in Clinical Operations Quality Initiatives.
  • Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
  • Performs administrative duties in a timely manner as assigned.
  • Assures site compliance with the routine protocol and regulatory requirements and quality of data.
  • May resolve routine monitoring issues.
  • Assists in the setting and updating of study timelines.

Skills and Requirements:

  • Bachelor's or Master's degree with relevant project management experience.
  • Must have 4+ years of experience within Clin Ops/Clinical Trials. CRC/CRA background highly preferred.
  • Working knowledge of ICH/GCP required. Phase research experience preferred.
  • Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials and ability to understand clinical study protocols.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at (+1) 215-531-5643 or c.nguyen@proclinical.com.

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.

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