Clinical Trial Management Associate

Highly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), Clinical Scientist
  3. United States
San Mateo, USA
Posting date: 10 Nov 2020

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

Job Responsibilities:

  • Serves as the key biomarker operational contact with internal and external stakeholders, for successful implementation of biomarker strategy in Gilead (GS) and Collaborative (CO) programs
  • Participate in multiple Phase 1-3 teams to manage biomarker implementation in clinical trials
  • Plans and coordinates all operational activities required with the collection, delivery and analysis of biomarker samples within a clinical trial
  • Provides sample management expertise to the Study Management Teams (SMTs)
  • Accountable for ensuring biomarker samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
  • Translate sample processing and handling instructions from research setting to the clinical setting
  • Provides the day-to-day operational management of biomarker vendors to ensure
    delivery against contracted scope of work
  • 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
  • Participate oral presentations as applicable
  • Assist in selecting Contract Research Organizations (CROs) or vendors as needed
  • Assist with the setting and updating of study timelines
  • Participate in departmental, or interdepartmental, strategic initiatives under general supervision
  • Conduct vendor visits and provide site training, as needed under general oversight
  • Review of protocols, informed consents, and relevant study documents

Skills and Requirements:

  • 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
  • At least 3+ years of clinical experience and a BS or BA in a relevant scientific discipline
  • Pharmaceutical industry experience and experience working as a clinical trial coordinator within a clinical trial setting
  • Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples is a plus

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.