Senior Clinical Data Manager

Job Title: Senior Clinical Data ManagerLocation: Plainsboro NJDuration: 6+ Months Act as the point of contact for DM activities for multiple trials, Â provide oversight of data collection and management per regulatory and industry standardsProvide oversight of the DM CRO and ensure performance against key indicators; provide DM expertise to trial teamsLead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy. Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategyReview CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structureDefine and perform data quality checks and take action to ensure data qualityProvide oversight of key DM documentation and ensure inspection readiness; ensure documentation is aligned with best practices and provide improvement recommendations based on DM expertiseDrive DM oversight of data releases/DBLs and ensure timely delivery of data deliverables in accordance with SOPs and ICH/GCP;Â ensure data quality for analysis and reporting; prepare for regulatory filings and inspectionsDrive and support vendor qualification for data management; define/specify scope of work for functional tasksSupport process improvement and knowledge management by participating in or leading task forces/ projectsSpecialist Data Mgmt.Act as the point of contact for start-up DM activities for multiple trials/assetsProvide oversight of the DM CRO and ensure planning, coordination of DM start-up activities and timely delivery of high-quality clinical databaseProvide input to trial design, protocols and amendments to ensure protocol enables proper data collection to support analysis and reportingGather data collection requirements from stakeholders for EDC/other applications that collect clinical trial data; lead data collection approach for new data typesEnsure eCRF/DTS specifications are aligned with industry standards, CDISC requirements and company clinical data collection standardsReview CRFs/DTSs to ensure alignment with protocol. Perform user acceptance testing of the eCRF/DTS; ensure clinical database structure meets expectations and is aligned with analysis needs; investigate and problem solve data collection/transfer issuesLead the data collection strategy; provide input to data capture tools for the trial.Develop, maintain and govern clinical data collection standardsProvide oversight of key DM documentation and inspection readiness of documentation; ensure documentation is aligned with best DM practicesDrive and support vendor qualification for data management; define/specify scope of work for functional tasksSupport process improvement and knowledge management by participating in or leading task forces/ projectsResponsibilities:- Provide oversight and review of data delivered by third-party external providers, ensuring high-quality data collection and testing services on behalf.- Liaise with internal stakeholders (Biomarker Operations, Data Management (DM), Data Analytics, Medical, Statistics, etc.) and external partners to streamline the data collection strategy, aligning with the trial's analysis, reporting, and exploratory research needs.- Develop and implement study-specific third-party data reconciliation plans in collaboration with DM CROs.- Oversee DM CROs for quality reconciliation of external data, ensuring seamless integration into the study database.- Collaborate with cross-functional teams, external vendors, and DM CROs to resolve data issues efficiently.- Manage third-party vendors and central labs, including performance reviews, issue resolution, and process improvement initiatives.- Ensure timely delivery of external data, overseeing timelines and deliverables effectively.- Support process improvement and knowledge sharing within the data management and external data teams.Requirements:- Bachelor’s degree in science or a related field.- 5–8 years of experience in external data management, including third-party vendor oversight and clinical data management within pharmaceutical, biotechnology, or CRO settings.- Proficiency in external data reconciliation with strong knowledge of diverse data types, testing methodologies, and biomarker testing—preferably in oncology trials.- Excellent project management, communication, and problem-solving skills, with the ability to collaborate effectively across multidisciplinary teams.- Highly organized and adaptable professional, capable of managing multiple priorities independently in a dynamic, fast-paced environment; familiarity with EDC and clinical trial data systems is advantageous.