Company : Bristol Myers Squibb Location : Boudry Neuchâtel From : Neuvoo CH
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BristolMyersSquibb 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.
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careers.Bms.Com/working-with-us.
The SeniorManager,ClinicalDataManagement (DataManagement Lead) is a role considered essential to the sustainability and success of the BMS R&D pipeline.
This role reports to the Director, ClinicalDataManagement or Associate Director, ClinicalDataManagement (Line Manager) within the Global DataManagement and Centralized Monitoring function of Global Development Operations (GDO).This is an office-based position across multiple BMS offices at Princeton/Lawrenceville NJ, Berkeley Heights NJ, & Boudry, Switzerland.
This strategic role is responsible for:
Project Management and LeadershipProvides clinicaldatamanagement leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projectsEfficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projectsResponsible for end to end clinicaldatamanagement activities and serves as a primary point of contact for internal and external study team membersProvides strong quality and project oversight over third party vendor responsible for datamanagement deliverablesTakes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway).
Enforces data standard conventions and quality expectations for clinicaldata per defined processesAuthors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardizationChairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completenessRepresents DM on cross-functional project teams & submission TeamsLead or support the Health Authority inspections and auditsProvides coaching and quality oversight of junior DataManagement LeadsFSP/CRO/Vendor OversightMay act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end DataManagement activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)Continuous improvement initiatives Lead/provide the relevant support and input to continuous improvement activities within clinicaldatamanagementProvides support for CAPA implementation as requiredExperience and Expertise Required Bachelor’s degree required with an advanced degree preferred.At least 5 years of relevant industry experience.Project management certification (e.G.
PMP) is desirable.Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendorsSound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding datamanagementStrong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collectionStrong project management; Exhibits expertise in metrics analysis and reporting methodologiesExcellent oral and written communication skillsCommunicate effectively with seniormanagement and cross-functional teamsKnowledge of submission requirements, [e.G.
New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]Travel Requirements5-10%Around the world, we are passionate about making an impact on the lives of patients with serious diseases.
Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.BristolMyersSquibb 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.Around the world, we are passionate about making an impact on the lives of patients with serious diseases.
Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.BristolMyersSquibb 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.
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 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. BristolMyersSquibb BoudryNeuchâtel
