Job Description
Working with UsChallenging. 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 stakeholdersCoordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team membersCoordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targetsDevelops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are metLeads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/sAssessment and set up the of vendors during study start up period (locally)Investigator Meeting participation and preparationEnsures 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 personnelValidation 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 VisitsResponsible 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 issuesCoordination of database locks and query follow up. Ensures timelines are metEnsure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre- inspection activitiesCoordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findingsDrives CAPA review, implementation and completionLead study team meetings locallyReviewing 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 outMay act as point of contact for SitesMay support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instancesAdditional 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-registrationalProvide 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 neededCommunicates 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 filingPreparation, 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 identifiedDegree/Certification/Licensure:Bachelor's degree required preferably within life sciences or equivalentExperience – Responsibility and minimum number of yearsClinical Trial Manager: Minimum of 4 years' industry related experienceExperience in leading or participating as an active member of cross functional teams, task forces, or local and global initiativesCompetencies – knowledge, skills, abilities, otherThorough understanding of GCP, ICH Guidelines and Country regulatory environmentIn depth knowledge and understanding of clinical research processes, regulations and methodologyUnderstands clinical landscape with practical knowledge of a variety of medical settings and medical records managementSoftware that must be used independently and without assistanceMicrosoft SuiteClinical 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 CareersWith 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 ProtocolBMS 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 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.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/Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
