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Clinical Trial Manager
3 weeks ago
Responsibilities:
Lead or manage components of Phase I, II, or III clinical studies.
Oversee operational activities related to the collection, delivery, and analysis of biological samples within clinical trials.
Manage study timelines, documentation, and communications.
Serve as the point of contact with internal and external stakeholders to ensure successful implementation of biological sample analysis strategies.
Assist Biomarker Sciences, Clinical Virology, and/or Clinical Pharmacology in vendor selection.
Coordinate interactions and deliverables from vendors.
Participate in and manage project meetings and conference calls with CROs, vendors, and cross-functional teams.
Participate in the functional review of study protocols and related documents such as clinical sample management plans and study communication plans.
Review and approve main and optional informed consents, and other study-specific informed consents as needed.
Contribute to SOP development and participate in special projects.
Develop tools and processes to optimize project efficiencies and effectiveness.
Proactively identify and address potential operational challenges, collaborating with key stakeholders to ensure study execution stays on track with projected budgets and timelines.
Ensure all work complies with established practices, policies, and regulatory requirements including FDA, EMA, ICH guidelines, and GCP standards.
Experience:
MA/MS/PharmD/PhD with a minimum of 2 years of relevant clinical or related experience in life sciences; or
BA/BS/RN with a minimum of 4 years of relevant clinical or related experience in life sciences.
Proven experience in managing the work of external vendors.
Demonstrated proficiency in Clinical Trial Management Associate (CTMA) grade 25 responsibilities.
Sample management experience.
Strong proficiency in Microsoft Office Suite.
Excellent communication skills.
Experience in clinical operations or bioanalytical operations.
Laboratory (bench) experience.
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