Clinical Trial Manager

3 weeks ago

Foster City, United States ACL Digital Full time

Title: Clinical Trials Manager

Location: Foster City, CA (Hybrid)

Duration: 06 months


Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all therapeutic areas. Clinical Operations plays a key role in ensuring all clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports

global registration and commercialization of products.

You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional team members. You will manage certain

components of clinical studies and act as a member of the study team. You will also manage biomarker and bioanalytical vendors. You will assist in the review of clinical study

protocols and other study documents, contribute to process development and/or participate in special projects. You may also participate in strategic initiatives.

Example Responsibilities:

• Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation of biomarker and

bioanalytical strategies in Collaborative (CO) programs

• Participate in multiple Phase 1-4 clinical study teams

• Plans and coordinates all operational activities required with the collection, delivery and analysis of biological specimens within a clinical trial

• Provides sample management expertise to the Study Management Teams (SMTs), Biomarker SubTeams (BSTs), and Clinical Pharmacology Subteams (CPST)

• Accountable for ensuring biological samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed

consent.

Minimum Education & Experience

• PharmD / PhD with 2+ years’ relevant clinical or related experience in life sciences.

• MA / MS with 3+ years’ relevant clinical or related experience in life sciences.

• BA / BS / RN with 5+ years’ relevant clinical or related experience in life sciences.

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