Key Responsibilities:
- Manage components of Phase I-III studies, including timelines, documentation, and communications.
- Assist in vendor selection for Biomarker Sciences, Clinical Virology, and Clinical Pharmacology, coordinating deliverables and interactions with vendors.
- Act as operational contact for assigned clinical studies.
- Plan and coordinate activities for the collection, delivery, and analysis of biological samples within clinical trials.
- Serve as the point of contact for internal and external stakeholders to ensure the implementation of biological sample analysis strategies in both internal and collaborative programs.
- Participate in project meetings, conference calls with CROs, vendors, and cross-functional teams.
- Contribute to protocol and study document reviews, including clinical sample management plans and study communication plans.
- Review and approve informed consents and study-specific documents.
- Identify operational challenges and collaborate with stakeholders to provide solutions, ensuring adherence to timelines and budgets.
- Contribute to the development of SOPs, tools, and processes that enhance project efficiency.
- Ensure compliance with applicable regulations, SOPs, and policies.
Qualifications and Skills:
- Education & Experience:
- MA/MS/PharmD/PhD with 2+ years of relevant clinical or life sciences experience.
- BA/BS/RN with 4+ years of relevant clinical or life sciences experience.
- Experience managing external vendors and knowledge of full-cycle clinical study management.
- Proficiency required for Clinical Trial Management Associate (CTMA) grade 25 position.
- Knowledge & Competencies:
- Strong knowledge of FDA, EMA, ICH guidelines, and GCP.
- Understanding of clinical operations principles and industry standards.
- Familiarity with medical and scientific terminology.
- Ability to adapt to changing environments and work effectively across multiple projects.