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Manager, Clinical Trial (m/f/d) - fixed-termChallenging. 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.Position Summary: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.Position Responsibilities: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 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 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 activitiesCoordinates, 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 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 act as point of contact for SitesMay support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.Depending on the experience and previous knowledge of the specific candidate, the position may be adjusted to the Senior Level.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 globallyServe 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)Position Requirements:Degree Requirements:Bachelors or Masters degree required. Field of study within life sciences or equivalentExperience Requirements: Clinical Trial Manager : Minimum of 4 years' industry related experienceSenior Clinical Trial Manager : At least 6 years of industry related experienceExperience in leading or participating as an active member of cross functional teams, task forces, or local and global initiativesKey Competency Requirements:Thorough 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 managementDemonstrated organizational and planning skills and independent decision-making abilityStrong organization and time management skills and ability to effectively manage multiple competing prioritiesAbility 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 levelsSkilled in the use of technologyGood verbal and written communication skills (both in English and local language).Software that must be used independently and without assistance (e.g., Microsoft Suite):Microsoft SuiteClinical Trial Management Systems (CTMS)Electronic Data Capture Systems (eDC)Electronic Trial Master File (eTMF)Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.This fixed-term role is meant as maternity cover until 30.06.2025.#LI-HybridIf 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Link *
Munich Germany


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