Senior Clinical Data Management Lead

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.

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, cell therapy, immunology, fibrosis and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The RoleThe Senior Manager, Clinical Data Management (Data Management Lead) is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Director, Clinical Data Management or Associate Director, Clinical Data Management (Line Manager) within the Global Data Management and Centralized Monitoring function of Global Development Operations (GDO).

ResponsibilitiesProvides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects.Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects.Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members.Provides strong quality and project oversight over third-party vendors responsible for data management deliverables.Takes 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 clinical data per defined processes.Authors, 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 standardization.Chairs Data Quality Review meetings with cross-functional study team members to ensure ongoing review of trial data currency, quality and completeness.Represents DM on cross-functional project teams & submission Teams.Lead or support the Health Authority inspections and audits.Provides coaching and quality oversight of junior Data Management Leads.FSP/CRO/Vendor OversightMay act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA).Continuous Improvement InitiativesLead/provide the relevant support and input to continuous improvement activities within clinical data management.Provides support for CAPA implementation as required.Experience and Expertise RequiredBachelor'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 vendors.Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management.Strong 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 collection.Strong project management; Exhibits expertise in metrics analysis and reporting methodologies.Excellent oral and written communication skills.Communicate effectively with senior management and cross-functional teams.Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)].Travel Requirements5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed).Additional InformationBMS 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.#J-18808-Ljbffr