Clinical Trial Manager

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.

Description:

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.

Summary:

Accountable for clinical trial execution and oversight at country and site level. Manage trial from study start through database lock/study closure. Maintains effective communication with internal/external stakeholders, serves as the primary BMS contact for the sites. Responsible for eTMF completion, coordination and development of CAPA, implementation of country audit level findings, coordination of database locks, resolution of discrepancies, preparation of country specific documents, and inspections readiness for assigned trials. Skilled in the use of technology.

Responsibilities:

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

• May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.

Degree Requirements:

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

Experience requirements:

• 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

Key Competency Requirements:

• Thorough understanding of GCP, ICH Guidelines and Country regulatory environment

• In depth knowledge and understanding of cl