At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
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 ofcountry 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.
Senior Level Expectations:
•Engage with Protocol Manager, line management and/or Head of Clinical Operations to assist in the resolution of complex issues both locally and/or globally
•Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Requirements:
Bachelors or Masters degree required. Field of study within life sciences or equivalent
Clinical Trial Manager: Minimum of 4 years' industry related experience; Senior Clinical Trial Manager: At least 6 years of industry related experience
Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
In depth 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 abilit
Strong organization and time management skills and ability to effectively manage multiple competing priorities
Ability of critical thinking and risk analysis
Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational level
Skilled in the use of technology
Good verbal and written communication skills (both in English and local language).
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
