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 .

Role Summary:

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

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

Additional responsibilities:
Responsible for the end-to-end management of budgeting and contracting for Study Teams with a focus on contracting a variety of contracts & study types including Confidential Disclosure Agreements (CDAs), Investigator contracts for BMS sponsored studies, non-registrational
Provide knowledgeable single-point of service to study teams related to study budgets and contracts
Prepare study /site level grant budgets
Manage the end-to-end process for executing Clinical Trial Agreements (CTAgs) with investigator sites
Prepares contract documents from templates and modify to reflect unique aspects of the particular study, including (the CTAg financial appendix)
Negotiates financial and legal aspects of CTAg and Master Service Agreements with sites, Institutions or vendor personnel
Is trained on legal fall back language and works with Legal as needed
Communicates clearly and efficiently with BMS Clinical and Legal Teams regarding amendments and other issues Enter CTAg, documents and data into Clinical Trial Management System and contract management software and ensure correct filing
Preparation, negotiation and execution of Master Agreements with Institution
Develop and maintain template language in collaboration with legal for all contract types. Would include maintenance of associated back-up language
Escalate to appropriate BMS colleague when a significant risk to the business is identified

Degree/Certification/Licensure:
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

Competencies – knowledge, skills, abilities, other
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

Software that must be used independently and without assistance
Microsoft Suite
Clinical Trial Management Systems (CTMS)
Electronic Data Capture Systems (eDC)
Electronic Trial Master File (eTMF)

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
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto 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.

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