responsible for leading and coordinating the end-to-end quality deliverables of data management activities for clinical trial including study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. Ensure activities are completed according to agreed standards and timelines; serve as representative in the study team; provide comprehensive data management expertise and support to team members; coordinate cross functional teams to ensure the flawless conduct of a clinical trial. Key Responsibilities: • Assuming Lead Data Manager (L-DM) role and autonomously acting as one of study team core member; liaises directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Risk Based Monitoring, Pharmacovigilance, Quality, etc.) to lead all data management activities for assigned study, discuss timelines and provide study Data management reporting. • Proposes solutions for data management issues that arise during the conduct of a study, and monitor until resolution. • Assuming the planification of all data management activities, considering the overall study timelines and ensure DM activities are conducted as planned. • Leading and coordinating internal DM delivery team (Database Developers, Data Management Programmers and Data Management Specialists) assigned on the study; working as a mentor for new Data Managers and accountable for the quality of data management deliverables. • Accountable for the DM study deliverables, such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports as per company standards and protocol requirements. • Assures that data management standards are followed. • Manages study document archiving in eTMF according to eTMF guidance. • Participates in Investigator Meetings and other outside meetings if required. Maintains knowledge of current regulations and technologies related to the data management function. • Defining and implementing the study data cleaning and validation strategy integrating risk based approach. • Involved, as Contributor or Leader, according to the defined processes, in protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, data surveillance and other review activities during the conduct of study. • Coordinating, in collaboration with vendor external data activities : load, integration activities and reconciliation activities, including External Lab data, eCOA, IRT integration etc. • Participating in the implementation of department initiatives. • Implements and oversees processes and coordinates activities in conjunction with the internal team and Team Leader. • Continually evaluates DM processes and applications for improvements. • Participates in working groups to develop and implement new procedures. • Managing service providers (CROs) independently on data management activities and maintains a good working relationship with vendor. • Reviews vendor proposal and contract for inclusion of appropriate scope of work, pricing and agreed services. • Performs assessment of vendor performance trends and service risks. • Meets regularly with vendor representative to implement mitigation actions. Obtains appropriate approval for scope of work and budget update. Reviews and approves vendor invoices based on the contract. Ensures all vendor contract related documents are processed on-time.
· Lead GDM for multiple moderate and high complexity studies, responsible for data management activities from startup, study conduct through database lock, submission, and close-out. Ensure all DM milestones/deliverables within targeted timelines and with quality.
· Collaborate with cross functional team including clinical (SRP/SRS), operations (GTL/CTM), biostats & programming, PK/CP, CMM, etc. to establish, align and confirm expectations for assigned studies.
· Manage DM CRO on data management activities, build and maintain good relationship.
· Setup study timelines, discuss issues, risks and mitigations, and ways to improve processes for successful outcome.
· Manage resources for the assigned studies, bring them up to speed and delegate tasks as appropriate. Mentor DM academy and new GDMs as needed.
· Generate EDC setup packages (forms, fields, folder structure, dynamics, roles and rights), eCRF completion guidelines, data management plan, data flow diagrams, data validation specifications, coding specifications, vendor data transfer agreement specifications, SDTM setup packages and TOQC plan.
· Lead SAE reconciliations, protocol deviations, coding listings, offline listings/PD listings and vendor data reconciliations. Contribute to protocol review and study management plan, etc.
· Perform data QC on SDTM data to ensure data consistency within the clinical DB and query sites as necessary.
· Coordinate interim and final DB locks and support FDA/PDMA submissions.
· Complete trainings for Janssen SOPs/ WIs, policies, and regulatory requirements, standard and oncology library releases timely to ensure assigned studies in compliance.
· Provide eCRF trainings to LTM/SMs and participate in investigator meetings.
· Upload DM documentations into VTMF per VTMF content map, ensure real time inspection readiness. Participate in regulatory agency inspections and J&J internal audits from DM perspective.
· Serve as subject Matter Expert (SME) to improve business.
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