Clinical Trial Management Associate job in San Mateo, USA

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Job type: Permanent

Discipline: Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), Clinical Scientist

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

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