Clinical Trial Manager

Bristol Myers Squibb • Malibu, SC

2d • $103,560 - $125,495

About The Position

The Clinical Trial Manager (CTM) is accountable for end-to-end study operational oversight and delivery at country level, ensuring adherence to timelines, budget, and quality standards. The CTM acts as the primary point of contact at the country level for internal and external stakeholders, ensuring clear communication, effective coordination, and successful project execution.

The position coordinates country-level study activities from feasibility and start-up through recruitment, conduct, database lock, inspection readiness, and site closeout as applicable. It works with global and local study teams, the Global Trial Acceleration Centre (GTAC), vendors, sites, regulatory and ethics bodies, and other stakeholders. The CTM supports country submissions and approvals, ensures accurate and complete study documentation and systems, manages risks and issues, and coordinates CAPA activities.

The role requires a bachelor's or master's degree in life sciences or an equivalent field and at least four years of industry-related experience. Occasional local travel is required, at less than one month per quarter. The position is listed with a U.S. starting pay range of $103,560–$125,495 for full-time employees.

Requirements

• Bachelor's or master's degree in life sciences or an equivalent field.
• Minimum of 4 years of industry-related experience.
• Deep understanding of GCP, ICH Guidelines, and local guidance, regulations, and codes of practice related to Clinical Research and Medical Affairs.
• Knowledge and understanding of clinical research processes, regulations, and methodology.
• Understanding of the clinical landscape, with practical knowledge of a variety of medical settings and medical records management.
• Demonstrated organizational and planning skills and independent decision-making ability.
• Strong organizational and time-management skills, including the ability to manage multiple competing priorities effectively.
• Interpersonal, oral, and written communication skills to influence, inform, or guide others.
• Good verbal and written communication skills in English and the local language.
• Ability to use Microsoft Suite, CTMS, eDC, and eTMF independently and without assistance.
• Experience leading or actively participating in cross-functional teams, task forces, or local and global initiatives.
• Occasional local travel, less than one month per quarter.

Responsibilities

• Serve as the main country-level point of contact for global study team members and coordinate with local country cross-functional teams.
• Implement local country and site feasibility processes, including proposing and validating country study targets as endorsed by country leadership.
• Plan, develop, and execute study start-up timelines and activities with the local study team, GTAC, and other stakeholders.
• Implement country- and site-level patient recruitment strategies and risk mitigation, coordinating efforts to meet enrollment targets and timelines.
• Lead problem-solving and resolution efforts, including risk and contingency management, issue resolution, and escalation.
• Assess and set up local vendors during study start-up.
• Participate in and prepare for Investigator Meetings.
• Keep CTMS data current and complete; ensure country and site personnel have access to eDC and vendor systems; enter necessary data and upload documents to eTMF.
• Validate study-related materials, including protocols, informed consent forms, and patient materials.
• Support review of country- and site-specific documents and, where applicable, prepare site-level informed consent forms and other documents.
• Support preparation of materials for Site Initiation Visits when needed.
• Verify and confirm eTMF completeness at country and site levels with the local team.
• Prepare investigator sites to conduct trials by verifying the acceptability of Clinical Trial Package documentation.
• Acknowledge Site Monitoring Visit reports, take action within specified timelines, escalate issues, and ensure appropriate documentation.
• Coordinate database locks and query follow-up, ensuring timelines are met.
• Ensure inspection readiness for assigned trials within the country and support Health Authority inspections and pre-inspection activities.
• Coordinate and complete CAPAs and ensure implementation for country audit-level findings; drive CAPA review, implementation, and completion.
• Coordinate local study team meetings.
• Support GTAC in resolving site-invoice queries and coordinate patient compensation claims where applicable.
• Collaborate with the local study team to support site relationship management, including CRO-related issues where relevant.
• Support Investigator Site Assessment Visits and Site Initiation Visits as needed.
• Perform site closure activities, including post-closeout, when needed.
• Act as a point of contact for sites when needed.
• Prepare or support submissions to Health Authorities as required by country requirements, including follow-up through approval and submissions for substantial amendments and other required documentation.
• Submit materials to Ethics Committees and governance offices where applicable and follow up through approval; coordinate Ministry of Health responses with regulatory and central teams as applicable.
• Support collection and distribution of documents to and from sites.
• Support approval for closure of funds and purchase orders.
• Update national registries where applicable.
• Serve as a coordinating resource on country regulatory requirements and stay current with evolving regulations in collaboration with Regulatory and Legal.

Benefits

• Wellbeing support.
• Retirement and financial protection benefits.
• Medical, dental, vision, life, and disability insurance offerings.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• Eleven paid company holidays each year.
• For specified employee groups, 160 hours of paid vacation annually for new hires, subject to manager approval, and three optional holidays.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level