Overview
Challenging. Meaningful. Life-changing. Bristol Myers Squibb offers work that transforms the lives of patients and supports career growth with opportunities across the organization. We provide balance and flexibility with a variety of competitive benefits, services and programs.
Position Purpose: 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. Acts as the primary point of contact at a country level for internal and external stakeholders to ensure clear communication, effective coordination, and successful project execution.
Key Responsibilities
* Act as the main point of contact for a country with global study team members and coordinate with local country cross-functional teams.
* Implement the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership.
* Plan, develop and execute timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) 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 in collaboration with relevant stakeholders.
* Lead problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholders.
* Assess and set up vendors during study start-up period (locally).
* Participate in Investigator Meetings and prepare materials for Site Initiation Visits.
* 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. Enter necessary data and upload documents in eTMF.
* Validate study-related materials (e.g., protocol, ICF, patient material) and support review of country and site-specific documents. Verify eTMF completeness at country and site level.
* Prepare investigator sites for clinical trials by verifying acceptability of Clinical Trial Package (CTP) documentation and completing site closure activities.
* Acknowledge Site Monitoring Visit reports, take timely action, escalate issues and document actions.
* Coordinate database locks and query follow-up to meet timelines.
* Ensure inspection readiness of assigned trials within country and provide support for Health Authority inspection and pre-inspection activities.
* Coordinate and complete CAPA (Corrective Actions / Preventive Actions) and ensure implementation for country audit findings; drive CAPA review, implementation and completion.
* Coordinate study team meetings locally and collaborate to manage site relationships.
* Prepare or support submissions to Health Authorities including follow-up until approval (substantial amendments and other HA submissions).
* Submit to Ethics Committees and governance offices, including follow-up until approval; coordinate MOH responses with regulatory and central teams.
* Serve as a coordinating resource on country regulatory requirements and stay up to date with evolving regulations in collaboration with Regulatory and Legal.
Disclaimer: The responsibilities listed above are a summary; other responsibilities may be required as assigned.
Qualifications, Experience, Competencies & Systems
* Minimum of 4 years’ industry-related experience.
* Experience leading or participating in cross-functional teams, task forces, or local/global initiatives.
* Ability to act as a key resource, providing guidance, training and mentoring to peers.
* Subject Matter Expert (SME) in areas such as therapeutic area, systems or processes across the department with potential regional/global contributions.
* Deep understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs.
* Knowledge of clinical research processes, regulations and methodology; practical knowledge of various medical settings and records management.
* Strong organizational, planning and multi-priority management skills; effective communication skills to influence and guide others.
* Proficiency with Microsoft Suite, CTMS, eDC and eTMF.
BMS is committed to equal employment opportunities and reasonable accommodations. Applicants can request accommodations during the recruitment process. See our Equal Employment Opportunity statement for details. BMS supports vaccination for Covid-19 where applicable and recommends staying up to date with boosters.
On-site and hybrid working models are determined by role type and occupancy designations. This role may require onsite presence as described by site-essential or hybrid work policies.
– This job description is subject to change and does not constitute a contract of employment. BMS is a Disability Confident Employer in the UK Government scheme.
#J-18808-Ljbffr