Clinical Trial Manager

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.

A BMS acredita que ter uma equipe diversificada de funcionários e uma cultura de inclusão é vital para a inovação e para executar de forma bem-sucedida nossa estratégia de negócios BioPharma.  Todas as nossas oportunidades são abertas para pessoas com deficiência (PCD), assim como para as demais dimensões no sentido mais amplo da diversidade, como gênero, idade, etnia, raça, orientação sexual & identidades, habilidades físicas, aparência, religião, origem socioeconômica, estilos de pensamento e experiências de vida.

Purpose/Objective of the job

Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure.

Serves as the main point of contact at a country level for internal and external stakeholders

Key Responsibilities and Major Duties

• Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members

• Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets

• Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met

• 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 Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel

• Validation of study related materials (i.e. protocol, ICF, patient material)

• Responsible for preparing country specific documents (e.g. global country specific amendment)

• Prepares materials for Site Initiation Visits

• Responsible for verifying and confirming with local team eTMF completeness (Country and Site level)

• Reviews 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, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.

• Lead study team meetings locally

• Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable)

• Management of Site relationships (includes CRO related issues)

• May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs)

• May perform site closure activities, including post-close out

• May act as point of contact for Sites

• Prepare submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances

• Degree/Certification

Bachelor's degree required preferably within life sciences or equivalent.

• Experience – Responsibility and minimum number of years

• Clinical Trial Manager: 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 initiatives

#LI-Hybrid

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

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  adastaffingsupport@bms.com . 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  TAEnablement@bms.com 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.

R1606812 : Clinical Trial Manager