Senior Clinical Trial Manager

Bristol Myers Squibb; Warszawa; On-site; PLN 272,000 - 329,000; Full time

Job summary

Bristol Myers Squibb is seeking a Clinical Trial Manager in Warsaw to oversee end-to-end study operations at country level, ensuring timelines, budget, and quality. You will coordinate with global study teams and local stakeholders to deliver successful clinical outcomes.

Responsibilities include start-up planning, site engagement, patient recruitment strategy, risk management, and ensuring data integrity in CTMS/eDC/eTMF.

Qualifications

• Bachelor's or master's degree in life sciences or equivalent.
• At least 5 years of industry-related experience.
• Experience in leading or contributing to cross-functional teams.
• Subject Matter Expert in therapeutic areas, systems, or processes.
• Strong knowledge of GCP, ICH guidelines and clinical research regulations.
• Understanding of clinical research processes and medical landscape.
• Excellent organizational, planning and time management skills.
• Strong verbal and written communication in English and local language.
• Proficient with Microsoft Office, CTMS, eDC and eTMF.

Responsibilities

• Serve as country lead and primary contact for the global study team and local cross-functional teams.
• Plan and execute country start-up timelines with GTAC and stakeholders.
• Lead patient recruitment strategies and meet enrollment targets.
• Manage risk, issues, and vendor setup during study start-up.
• Coordinate Investigator Meetings and site documentation preparation.
• Ensure CTMS/eDC/eTMF data is accurate and accessible for country/site personnel.

Skills

Cross-functional teamwork

Mentoring

Communication skills

GCP/ICH knowledge

Clinical research processes

Education

Bachelor's or master's (life sciences)

Tools

Microsoft Suite

CTMS

eDC

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.

Qualifications & Experience

• Bachelor's or master's degree required. Field of study within life sciences or equivalent
• At least 5 years of 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.
• 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

Travel Required (nature and frequency) - Occasional local travel requirement < 1 month/quarter

Compensation Overview

Warsaw - PL: zł271,580 - zł329,085

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606666 : Senior Clinical Trial Manager