• The Clinical Trials Manager will play a pivotal role in supporting the global execution of Phase I-IV clinical trials across therapeutic areas. This role involves working collaboratively with cross-functional teams to ensure all trials comply with regulatory guidelines, company policies, and industry best practices, while delivering high-quality clinical data that supports global product registration and commercialization.
• The ideal candidate will have robust experience in clinical operations, biomarker sciences, and vendor management. You will manage specific components of clinical studies, coordinate biomarker and bioanalytical vendor activities, and contribute to process improvement initiatives.

Key Responsibilities

Operational Leadership

• Act as the primary operational liaison for biomarker and bioanalytical strategies in clinical programs.
• Coordinate the operational activities required for biological sample collection, delivery, and analysis.
• Lead and participate in biomarker and bioanalytical operational meetings with study teams and vendors.
• Provide sample management expertise to Study Management Teams (SMTs), Biomarker Sub Teams (BSTs), and Clinical Pharmacology Sub Teams (CPSTs).

Vendor Management

• Serve as the primary operational interface between SMTs and laboratory vendors.
• Oversee day-to-day vendor operations, ensuring contracted deliverables align with study goals.
• Develop Requests for Proposals (RFPs) and contribute to vendor selection processes.

Protocol Development & Compliance

• Review protocols, informed consents, and other study-related documents.
• Ensure adherence to ethical standards and regulatory guidelines, including GCP, FDA, EMA, and ICH requirements.
• Address operational challenges, providing resolution strategies to keep biomarker initiatives on track.

Strategic Contributions

• Participate in special projects and departmental initiatives to enhance clinical operations processes.
• Develop tools and workflows to optimize study efficiencies.
• Provide clinical operations expertise to support recruitment, hiring, and team development.

Communication & Reporting

• Communicate protocol requirements to team members and stakeholders effectively.
• Contribute to interim and final study reports, ensuring data integrity and resolution of discrepancies.
• Present study updates at internal and external meetings, including investigator sessions.

Qualifications & Skills

Education

• PharmD / PhD with 2+ years of relevant experience in life sciences.
• MA / MS with 3+ years of relevant experience in life sciences.
• BA / BS / RN with 5+ years of relevant experience in life sciences.

Experience

• Proven ability to manage full-cycle study operations from initiation to close-out.
• Experience in biomarker strategy execution and vendor management.
• Strong understanding of clinical trial regulations (FDA, EMA, GCP, ICH).
• Familiarity with medical/scientific terminology and protocol requirements.

Skills

• Exceptional communication and leadership skills in a cross-functional team environment.
• Strong problem-solving abilities and adaptability to dynamic project demands.
• Advanced knowledge of study management tools and best practices.
• Proficient in maintaining operational databases and document repositories.

Pay Range: $60/hr to $80/hr