Clinical Trial Manager

Bristol-Myers Squibb; Madrid; On-site; EUR 55,000 - 75,000; Full time

Job summary

Bristol Myers Squibb seeks a Clinical Trial Manager to oversee end-to-end study operations at the country level, ensuring timelines, budget adherence, and quality. You will coordinate with global study teams and local cross-functional groups to deliver trials successfully.

The role emphasizes feasibility, site coordination, recruitment strategies, data integrity in CTMS/eTMF, and regulatory submissions across the country. Strong communication and problem-solving are essential.

Qualifications

• Experience leading end-to-end country-level trial operations.
• Ability to coordinate with global study teams and local country teams.
• Strong focus on timelines, budget, and quality standards.

Responsibilities

• Acts as the main country-level contact for global study teams.
• Implements local country feasibility and targets in collaboration with leadership.
• Plans and executes start-up timelines with GTAC and study team.
• Manages country-level patient recruitment strategy and enrollment targets.
• Leads risk mitigation and issue resolution with key stakeholders.
• Ensures data in CTMS and eDC is current and accessible.
• Prepares and validates study materials (protocol, ICF, patient materials).
• Supports site initiation, monitoring, and CAPA processes at country level.
• Coordinates regulatory submissions, ethics approvals, and HA interactions.

Skills

Clinical Trial Management

Regulatory Knowledge

Cross-functional Coordination

CTMS/eTMF Familiarity

Tools

CTMS

eTMF

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

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.

Bristol-Myers Squibb Company is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity ©2022 Bristol-Myers Squibb Company. All rights reserved.

Disclaimer: The responsibilities listed above are only a