[Hiring] Clinical Trial Manager @Bristol Myers Squibb

Role Description

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 both internal and external stakeholders, ensuring clear communication, effective coordination, and successful project execution.

Key Responsibilities

• Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country cross functional teams.
• Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership.
• Plans, develops and executes 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. Coordinates and ensures country level study enrolment targets and timelines are met in collaboration with relevant stakeholders.
• Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s.
• Assessment and set up the of vendors during study start up period (locally).
• Investigator Meeting participation and preparation.
• Ensures data entered in the Clinical Trial Management System (CTMS) is current and complete, and access to eDC and vendor systems is available for the country and clinical trial site personnel. This includes entering necessary data and uploading documents in eTMF.
• Validation of study related materials (i.e. protocol, ICF, patient material).
• Supports the review of country and site-specific documents (e.g. ICF, patient material), and where applicable may include the preparation of site level ICF and other documents.
• May support preparation of materials for Site Initiation Visits.
• Responsible for verifying and confirming with local team eTMF completeness (Country and Site level).
• Prepare investigator sites to conduct clinical trials through verifying acceptability of Clinical Trial Package (CTP) documentation.
• Acknowledges Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
• Coordination of database locks and query follow up. Ensures timelines are met.
• Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities.
• Coordinates and completes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
• Coordinate study team meetings locally.
• Supports GTAC in the resolution of queries related to site invoices and supports in the coordination of patient compensation claims (if applicable).
• Collaborates with the local study team to support the management of site relationships (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 per country requirements, perform or support the preparation of submissions to Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
• Perform submission to Ethics Committees and governance offices, where applicable, including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission). Coordinate the MOH responses with regulatory and central teams, as applicable.
• May support the collection and distribution of documents to and from sites.
• Support the approval for closure of funds/POs.
• May update national registries where applicable.
• Serves as a coordinating resource on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and Legal.

Qualifications

• Bachelor's or Master's degree required. Field of study within life sciences or equivalent.
• Minimum of 4 years' industry related experience.
• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiative.
• Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other peer team members through a mentoring process using 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 the opportunity to contribute at a regional or global level with this expertise.
• Travel Required (nature and frequency) - Occasional local travel requirement < 1 month/quarter.

Requirements

• Deep understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs.
• Knowledge and understanding of clinical research processes, regulations and methodology.
• Understands 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 effectively 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 that must be used independently and without assistance: Microsoft Suite, CTMS, eDC, eTMF.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including 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 also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.