**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. 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 . **Position Summary:** The Clinical Trial Manager is responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure and serves as the main point of contact at a country level for internal and external stakeholders. Serves as the Project Manager for US Clinical Trial Management deliverables. Accountable for clinical trials execution, oversight at the country and site level and primary point of contact for the study. Engage with start-up teams in site selection activities, monitor conduct of clinical trials and manage the trial from study start through database lock/study closure according to SOPs, GCP and regulatory guidelines. **Responsibilities** + Coordinates and maintains effective communication and serves as the primary BMS contact for the site. Provide leadership and planning support to ensure delivery of the operational aspects of sites on assigned protocols with overall accountability for resourcing, deliverables and productivity. + Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets. + Responsible for eTMF completion, coordination and development of CAPA, implementation of country audit level findings, coordination of database locks, preparation of country specific documents, and inspections readiness for assigned trials. + Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met. + Responsible for eTMF completion, coordination and development of CAPA, implementation of country audit level findings, coordination of database locks, preparation of country specific documents, and inspections readiness for assigned trials. + Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion. + 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. + Demonstrates a full understanding of data management activities, monitor data quality and coordinate resolution of discrepancies. Skilled in the use of technology. Demonstrates a thorough understanding of all steps in the clinical research process. + Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities. + 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 Investigator Site Assessment Visits (ISAs) 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. **Qualifications and Experience** + Masters or Bachelors degree in Life Sciences, Allied Health, Nursing or Pharmacy, and a minimum of 4 years of clinically related or relevant 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 ability. + 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 levels. + Good verbal and written communication skills (both in English and local language). + Skilled in the use of technology. 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) The **starting compensation** for this job is a range from **$103,560-$140,120,** plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. 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 a supportive culture, promoting global participation 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 an 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/ (https://careers.bms.com/eeo-accessibility) 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. **Company:** Bristol-Myers Squibb **Req Number:** R1594149 **Updated:** 2025-08-14 03:41:05.731 UTC **Location:** Field Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.