**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** Accountable for end-to-end study operational oversight and delivery at country level, ensuring adherence to timelines, budget and quality standards. Acts as the primary point of contact at a country level for both internal and external stakeholders, ensuring clear communication, effective coordination, and successful project execution. **Position Responsibilities:** + Oversees and collaborates with study team members and cross-functional stakeholders, to proactively identify opportunities and manage and mitigate risks and to ensure timely and on-budget execution of clinical trial deliverables. + Supports internal audit and inspection activities and contributes to corrective and preventive actions (CAPAs), including leading the resolution of issues when appropriate. + Monitors updates throughout a study's lifecycle for compliance with regulations and standard operating procedures (SOPs), including contract research associate (CRA) compliance with study parameters and tracks escalation and closure of action items noted in monitoring visit reports during late phase studies including registration of protocols. + Monitors progress of clinical trials and identifies and resolves any issues or risks that may impact timelines or study outcomes. + Serves as the key operational contact for clinical studies, providing oversight for the site evaluation, initiation and close-out visits in addition to routine monitoring visits. + Participates in contract research organization (CRO) and vendor selection and manages all interactions and deliverables from relevant CROs and vendors under the guidance of leadership. + Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country cross functional teams. + Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership. + Plans, develops and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders. + Implement country and site level patient recruitment strategy and risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met in collaboration with relevant stakeholders. + 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 the Clinical Trial Management System (CTMS) is current and complete, and access to eDC and vendor systems is available for the country and clinical trial site personnel. This includes entering necessary data and uploading documents in eTMF. + Validation of study related materials (i.e. protocol, ICF, patient material). + Supports the review of country and site-specific documents (e.g. ICF, patient material), and where applicable may include the preparation of site level ICF and other documents. + May support preparation of materials for Site Initiation Visits. + Responsible for verifying and confirming with local team eTMF completeness (Country and Site level). + Prepare investigator sites to conduct clinical trials through verifying acceptability of Clinical Trial Package (CTP) documentation. + Acknowledges 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 and completes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion. + Coordinate study team meetings locally. + Supports GTAC in the resolution of queries related to site invoices and supports in the coordination of patient compensation claims (if applicable). + Collaborates with the local study team to support the management of site relationships (may include CRO related issues). + May support 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. + As required per country requirements, perform or support the preparation of submissions to Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission. + Perform submission to Ethics Committees and governance offices, where applicable, including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission). Coordinate the MOH responses with regulatory and central teams, as applicable. + May support the collection and distribution of documents to and from sites. + Support the approval for the closure of funds/POs + May update national registries where applicable. + Serves as coordinating resource on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and Legal. + Serves as a key resource for colleagues, by providing guidance, leading training and mentoring to other peer team members through a mentoring process using informal and/or formal presentations. + Serves as a Subject Matter Expert (SME) in areas such as therapeutic area, systems or processes across the department with the opportunity to contribute at a regional or global level with this expertise. **Qualifications & Experience** **Degree Requirements** + Bachelors or Masters degree required. Field of study within life sciences or equivalent **Experience Requirements** + Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives. + At least 6 years of industry related experience. **Key Competency Requirements** + 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. + Skilled in the use of technology. + Good verbal and written communication skills (both in English and local language). 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). Occasional local travel requirement \#LI-Hybrid 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:** R1594981 **Updated:** 2025-10-03 05:00:33.605 UTC **Location:** Bucharest-RO 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.