Clinical Trial Manager

Clinical Trial Manager – Rome

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About the Role

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

Key Responsibilities

• Act as main point of contact for a country with global study team members and coordinate with local country cross‑functional teams.
• Implement local country and site feasibility process, including proposal and validation of country study targets.
• Plan, develop and execute timelines and activities for start‑up in collaboration with the local study team and other relevant stakeholders.
• Implement country and site level patient recruitment strategy and risk mitigation; coordinate and ensure country level study enrolment targets and timelines are met.
• Lead problem‑solving and resolution efforts, including management of risk, contingencies, issue resolution and escalation to appropriate stakeholders.
• Assess and set up vendors during study start‑up period (locally).
• Participate in and prepare Investigator Meetings.
• Ensure data entered in the Clinical Trial Management System (CTMS) is current and complete, and that access to eDC and vendor systems is available for country and site personnel.
• Validate study related materials (protocol, ICF, patient material).
• Support the review of country and site‑specific documents, including preparation of site‑level ICF and other documents where applicable.
• May support preparation of materials for Site Initiation Visits.
• Verify and confirm with local team eTMF completeness (country and site level) and prepare investigator sites to conduct clinical trials.
• Acknowledge Site Monitoring visit reports, take action within specified timelines and elevate issues with appropriate documentation.
• Coordinate database locks and query follow‑up, ensuring timelines are met.
• Ensure inspection readiness of assigned trials within country and support Health Authority inspection and pre‑inspection activities.
• Coordinate and complete Corrective Actions / Preventive Actions (CAPA) and ensure implementation for country audit findings; drive CAPA review and completion.
• Coordinate study team meetings locally.
• Support the resolution of queries related to site invoices and patient compensation claims where applicable.
• Collaborate with the local study team to support site relationship management (may include CRO related issues).
• May support Investigator Site Assessment Visits (ISAs) and Site Initiation Visits (SIVs).
• May perform site closure activities, including post‑close‑out.
• May act as point of contact for Sites.
• As required, perform or support preparation of submissions to Health Authorities, including follow‑up until approval.
• Perform submission to Ethics Committees and governance offices, including follow‑up until approval.
• May support the collection and distribution of documents to and from sites.
• Support approval for closure of funds/POs.
• May update national registries where applicable.
• Serve as a coordinating resource on country regulatory requirements and keep up to date with evolving regulations.

Qualifications & Experience

• Bachelor’s or master’s degree required; field of study within life sciences or equivalent.
• Minimum of 4 years’ industry‑related experience.
• Experience leading or participating as an active member of cross‑functional teams, task forces, or local and global initiatives.
• Provide guidance, lead training and mentoring to peer team members through informal and/or formal presentations.
• Serve as a subject matter expert (SME) in areas such as therapeutic area, systems or processes across the department, with opportunity to contribute at a regional or global level.

Competencies

• Deep understanding of GCP, ICH Guidelines and local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs.
• Knowledge and understanding of clinical research processes, regulations and methodology.
• Understand 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 and ability to manage multiple competing priorities.
• Interpersonal, oral and written communication skills to influence, inform or guide others.
• Good verbal and written communication skills (both in English and local language).

Software & Travel

• Microsoft Suite
• CTMS
• eDC
• eTMF

Travel required occasionally.

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Research, Analyst, and Information Technology

Industry: Pharmaceutical Manufacturing

Equal Employment Opportunity Statement

BMS is an equal‑opportunity employer. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.