Clinical Trial Manager

Conteúdo do emprego

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Job Title: Clinical Trial Manager

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 the country and site feasibility process, including proposal and validation of country study targets
• Develop 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 vendors during the study start-up period (locally)
• Coordinate with payment vendor(s) to ensure timely payment to the investigational site.
• Investigator Meeting participation and preparation
• Ensures data entered in Clinical Trial Management 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)
• Review materials for Site Initiation Visits
• Responsible for verifying and confirming with the local team eTMF completeness (Country and Site level)
• Conduct data review per study data review plan
• Reviews Site Monitoring visit reports, take action within the timelines specified 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 the 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 managing patient compensation claims (if applicable)
• Management of Site relationships (includes CRO-related issues)
• Conduct country feasibility and may support Investigational Site Assessment (ISA) and Site Initiation Visits (SIVs)
• May support site closure activities, including post-close-out
• May act as the point of contact for Sites
• May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees, and other relevant instances.
  
  

Key Stakeholders/Contacts – describe this position’s key internal matrix relationships

and key external stakeholders/clients

Internal Stakeholders;

Clinical Scientist, Clinical Trial Physician, Global Trial Managers, Clinical Trial Monitors, Clinical Trial Associates (CTA),

Study Start-up Specialists, Site Contract Leads, Vendor Operations Managers, Site Relationship Managers, Regional

Clinical Compliance Leads, Central Data Reviewer (CDR), Data Management Leads, Line Managers (LM), Head of

Clinical Operations , local Regulatory and local Medical Affairs team

External Stakeholders;

Principal Investigator, Sub-Investigators, Study Coordinators, Research Nurses, Research Managers, Data Managers,

Pharmacists, Ethics Committees, Vendors, MOH Personnel (where applicable),

At least 4 years of Clinical Trials industry experience.

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

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.