Senior Clinical Trial Management Specialist

Job Description

Job Summary

The Senior Clinical Trial Management Specialist is responsible for the planning, execution, and oversight of clinical trials in compliance with regulatory requirements, ICH-GCP guidelines, and company SOPs. This role involves cross-functional collaboration, vendor and CRO oversight, site monitoring activities, and contribution to key clinical trial documents to ensure high-quality and timely trial delivery.

Key Responsibilities

• Lead and support CRO and vendor selection, including participation in RFP development, bid evaluations, and selection processes.
• Provide ongoing vendor and CRO management, including oversight of performance, timelines, budgets, deliverables, and issue resolution.
• Draft, review, and coordinate cross-functional input for clinical trial documents, including:
• Clinical protocols
• Informed consent forms (ICFs)
• Case report forms (CRFs)
• Monitoring plans
• Oversee and/or perform site monitoring activities, ensuring compliance with protocol, GCP, regulatory requirements, and company SOPs.
• Serve as a key liaison between internal stakeholders, CROs, vendors, and investigative sites.
• Track study milestones, risks, and issues; proactively develop and implement mitigation plans.
• Support study start-up, conduct, and close-out activities.
• Ensure accurate documentation, reporting, and maintenance of Trial Master File (TMF) content.

Qualifications

• Bachelor’s degree (BS or BA) in life sciences or a related field required.
• 4+ years of clinical trial management experience, preferably in a pharmaceutical, biotechnology, or CRO environment.
• Hands-on experience with site monitoring and study oversight.
• Demonstrated experience in CRO/vendor selection and vendor management.
• Strong understanding of ICH-GCP, FDA, and global regulatory requirements.
• Experience drafting and reviewing clinical trial documentation.
• Strong organizational, communication, and cross-functional collaboration skills.
• Ability to manage multiple priorities and work independently in a fast-paced environment.
• Experience working in a global clinical trial environment.
• Familiarity with electronic data capture (EDC) and CTMS systems.