Manager Data Management

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Manager, Data Management is accountable for end-to-end delivery of clinical data management services for assigned studies, collaborating with study teams, CROs, external vendors, and partners to ensure high quality deliverables are on time to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards. This position may manage multiple studies concurrently. This position will manage DM resources of assigned studies. This position requires a strong working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related applications, industry standards, and technical skills in working with data received from CROs and other external vendors. This position requires strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures. Additionally, this position requires knowledge of clinical operations, biostatistics, and relevant regulatory requirements. This position requires experience working on multiple phases within the medical device and/or pharmaceutical industry in one or more complex disease areas. This position requires experience in continuous improvement, project management, change management, and risk management. Responsibilities Leadership, Direction, and Strategy Establishes Data Management deliverables and expectations at the study level. Proactively identifies and manages risks to data quality and/or timelines at the study level and escalates issues to the DM program lead. Will manage DM resources of assigned studies; provides FSP/Vendor oversight for end-to-end Data Management activities. Acts as a core member of the Study Team and collaborates with other line functions to achieve study deliverables. Is an ambassador and Subject Matter Expert (SME) for DM. Participates in audits and inspections as the DM SME for the study. Project Management Is accountable for the conduct of Data Management activities for assigned studies (e.g., study startup, study conduct, study closeout, and monitoring adherence to quality expectations and timelines. Is responsible for proper planning of DM resources for assigned studies. Complies and ensures compliance of DM resources of assigned studies and vendors with the protocol, Policies, SOPs, external/internal standards, program standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines. Accountable for Data Management deliverables meeting/exceeding study team expectations regarding quality and time. Ensures Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements Functional Expertise: Study Start-Up Participates in Study Team’s start-up meeting to determine technology and study-specific data requirements. Meets with assigned DM staff and external vendor(s) to discuss data management responsibilities, timelines of deliverables, and development of study plans/documents. Reviews and approves study timeline for all DM study start-up, conduct, and close-out activities and ensures alignment with program timelines. Contributes feedback to authors of other cross-functional study documents such as the Clinical Protocol, Clinical Monitoring Plan, Statistical Analysis Plan, SAE Flow Plan, Medical Management/Medical Data Review Plan, Lab Plan, Randomization (IXRS) Plan, and Protocol Deviation Plan to ensure successful data collection, cleaning, and evaluation of study results and safety data reporting. Identifies need for and requests new study data standards; ensures consistency of incorporation of these and other DSI data standards across assigned studies. Reviews and approves DM study start-up documentation such as the CRF, eCRF completion guidelines, edit check specifications, Data Management Plan, Data Review Plan, electronic file transfer specifications for all vendors, study-specific listings, reconciliation specifications, and the UAT Plan ensuring incorporation of DSI data collection and cleaning standards. Participates in cross-functional review of data collection forms/methods (i.e., eCRF, ePRO, external systems/other data collection tools) and data cleaning/review tools for assigned studies; checks for consistency with program standards. Reviews User Acceptance Testing Plan for database, edit checks, reconciliations, and listings and oversees testing, validation, and implementation activities to ensure quality deliverable. Specifies to DM study resources the DM documentation list and location for study filing. Reviews and approves study-specific data management SIV/IM training slides for investigator meetings and site trainings. Authorizes release of database/EDC system into production. Study Conduct Ensures DM activities are executed according to timelines and quality expectations through collaboration with internal and external stakeholders (i.e., clinical data cleaning, external data transfers, SAE reconciliation, local lab data processing, medical coding, report specification review, study files management) Oversees data review process for assigned studies and performs data quality checks on an ongoing basis to ensure data quality and data integrity of clinical trial database and externally generated electronic data files. Reviews and manages updates to study DM documentation, specifications, and deliverables. Discusses and disseminates changes in planned data requirements and timelines to assigned DM resources of assigned studies and vendors. Evaluates impact of study changes and communicates required changes to the relevant study team members and/or assigned DM resources. Ensures appropriate changes are reviewed, approved, and implemented. Reviews study metrics, status reports, and adherence to timelines to ensure study expectations are met for data quality and timeliness. Identifies data trends, risks, and issues and determines and coordinates mitigation activities; escalates issues to DM Program Lead as needed. Attends study team meetings and provides information on risk mitigation as needed. Manages the review and approval of data deliverables for support of statistical analyses. Ensures the data files received from external vendor(s) are reviewed for compliance with the data specifications, data transfer plan, and external data standards (wherever applicable). Ensures filing of DM documentation and approval/signature forms on an ongoing basis within study’s Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements. Study Closure Oversees database lock preparation and ensures activities on checklist are completed. Obtains study team agreement on readiness for database lock; collects all appropriate signatures on the Clinical Database Lock Authorization Form. Notifies study team that database is locked; ensures final datasets are posted to the appropriate data repository folder. As needed, coordinates cross-functional activities for evaluation for database unlocking and re-locking. Reviews and endorses study’s TMF completeness and correctness by performing functional QC of filed DM documentation. Oversees and coordinates final end-of-study procedures (EDC site data provided for distribution to Sites, database archived and decommissioned). Operational Efficiency / Continuous Improvement Provides comprehensive data management expertise to study teams to optimize study-specific clinical trial processes. May participate in process improvement initiatives. Qualifications Education Qualifications (from an Accredited College Or University) Master's Degree in life sciences or related field (or equivalent experience) preferred Bachelor's Degree in life sciences or related field (or equivalent experience) required RN in life sciences or related field (or equivalent experience) preferred Experience Qualifications 5 or more years in Clinical data management and/or related industry work experience in a medical device, pharmaceutical, or biotechnology company, or similar environment (e.g., CRO); oncology, immunology, or complex disease clinical trial experience required Salary Range

USD$127,280.00 - USD$190,920.00

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. #J-18808-Ljbffr Daiichi Sankyo US