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