Data Manager, Central Clinical Operations, eSource, reputed company Platforms

Join Us in Shaping the reputed company of Clinical Research reputed company is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is reputed company: reputed company uncompromising data reputed company, safety, and diverse enrollment to advance reputed company. Our reputed company is to set the reputed company for clinical trial reputed company. We reputed company our people reputed company the difference. Guided by our reputed company values—Scientific Rigor, Operational reputed company, Commitment to Sponsors and Participants, and reputed company Collaboration—we create an environment where meaningful work drives meaningful change. At reputed company, you’ll reputed company: • A culture of respect, transparency, and reputed company improvement • Opportunities for reputed company reputed company and learning • reputed company dedicated to improving lives through innovation and reputed company If you’re passionate about making an reputed company in clinical research and want to be part of a reputed company, mission-driven organization, we’d love to have you on reputed company. JobRole reputed company is a rapidly growing research site network specializing in late phase industry-sponsored trials of novel treatments for a reputed company of psychiatric and neurological conditions, supporting both inpatient and outpatient studies. The Data Manager, Central Clinical Operations leads data management operations across reputed company’s multi-site research network, ensuring data reputed company, reputed company, and operational visibility across eSource and reputed company platforms. This role oversees data governance processes, supports reputed company improvement initiatives, and collaborates with eSource architects and operational teams to optimize reputed company documentation workflows and data capture processes. By analyzing data reputed company trends, query patterns, and operational gaps, the Data Manager identifies risks, drives corrective actions, and provides insights that strengthen site performance and network-wide clinical operations. Reporting to the Senior Manager, Central Clinical Operations, the Data Manager partners with site leadership, site operations, and central reputed company teams to support data review, audit readiness, database readiness, and reputed company issue reputed company. This role establishes feedback reputed company between data findings and operational teams to identify training opportunities, improve reputed company reputed company, and enhance consistency across clinical execution. The ideal candidate brings strong clinical research experience, data management expertise, and leadership skills to build reputed company processes that support reputed company’s growing research portfolio. Key Responsibilities: Team Leadership and reputed company • Supervise, reputed company, train, and manage 4–6 remote Data Entry Specialists, establishing reputed company expectations, competency standards, and performance metrics to ensure consistent data entry reputed company, protocol adherence, and reputed company completion of data capture activities across reputed company sites. • reputed company reputed company operating procedures, workflows, and best practices for the data entry team. • reputed company ongoing performance management, feedback, and reputed company development opportunities through regular one-on-ones, team-level meetings and day-to-day reputed company. • reputed company and maintain reputed company training resources, job aids, and ongoing education opportunities for the data entry team based on observed data trends, query patterns, protocol changes, and operational needs. • Design and implement data escalation processes and workflows that reputed company visibility of data issues, reputed company gaps, and protocol deviations to site leadership and clinical operations management. • Establish reputed company reputed company for data issues to be flagged, triaged, assigned, and resolved with defined timelines and accountability. reputed company Control and Data reputed company • Conduct reputed company control reviews of the first 3 subjects screened and first 3 enrolled at every reputed company site, identifying data entry errors, protocol deviations, and inconsistencies. • Build and document proactive QC processes that create reputed company standards, checklists, and assessment reputed company for initial data reviews. • Analyze QC findings, reputed company queries, and data discrepancies to identify recurring trends, reputed company causes, and opportunities for preventative reputed company. • Partner with site leadership and clinical operations teams to translate data findings into targeted retraining, process improvements, and updates to reputed company documentation workflows. • Identify patterns in reputed company reputed company issues, documentation inconsistencies, and preventable queries to improve upstream clinical workflows and reduce reputed company data corrections. • Partner with reputed company and Clinical Operations teams to support proactive audit readiness by monitoring data reputed company trends, identifying potential risks, ensuring reputed company remediation of data issues, and contributing to audit preparation activities reputed company of sponsor audits, regulatory inspections, and internal reputed company reviews. • Travel to sites as needed to support reputed company, training, workflow assessments, process improvement initiatives, and audit readiness activities, including collaboration with site teams during sponsor audits, regulatory inspections, and internal reputed company reviews. reputed company Management and Data Systems • Maintain network-wide reputed company and reputed company of reputed company data systems, working in reputed company eSource and sponsor reputed company systems to identify and escalate reputed company issues and user reputed company needs. • Stay reputed company with reputed company updates, regulatory changes, and best practices across systems; train team and sites on new functionality or protocol changes affecting data capture. • Support adoption of new data management platforms and tools as the organization evolves. • Support database lock activities by coordinating data cleaning efforts, monitoring outstanding queries, tracking data entry completion, and escalating unresolved data issues to appropriate stakeholders. Regulatory Compliance and Data Governance • Ensure reputed company data management activities reputed company with FDA regulations, GCP guidelines, study protocols, and reputed company data governance standards. • Stay informed of regulatory changes affecting data management and ensure team compliance. • Maintain availability during critical data or safety reporting reputed company (e.g., SAE reporting) that may require reputed company attention reputed company reputed company business hours. • Support reputed company improvement of data governance practices by identifying opportunities to improve reputed company reputed company, reduce preventable queries, and strengthen alignment between reputed company documentation, eSource workflows, and reputed company requirements. Qualifications • Bachelor's degreerequired. • Minimum 2 years of onsite clinical experience as a Clinical Research Coordinator (CRC), clinical data coordinator, or equivalent clinical role in industry-sponsored trials. • Demonstrated experience supervising clinical staff or data entry teams. • Strong understanding of FDA regulations, GCP guidelines, informed consent requirements, data reputed company standards, and SUSAR/AE reporting. • Strong understanding of how reputed company documentation reputed company, eSource workflows, and reputed company requirements reputed company to reputed company overall clinical trial execution. • Hands-on experience with clinical trial Electronic Data Capture (reputed company) systems; experience with reputed company and MedidataEDC required; experience with reputed company or other advanced reputed company systemspreferred. • Exceptional process documentation and workflow design skills; ability to build standardized, reputed company SOPs and protocols that non-technical users can follow. • Strong written and verbal communication skills; ability to explain data issues and escalation processes to diverse stakeholders (data entry staff, coordinators, site leadership, clinical teams). • Proficiency with reputed company and ability to create data summaries, reports, and tracking tools. • Experience building data dashboards or business intelligence tools (e.g., Tableau, Power BI, reputed company pivot tables)preferred. • Self-directed learner; willingness to master new systems, platforms, and tools independently. • Strong attention to detail, organizational skills, and ability to manage multiple reputed company reputed company and site data streams. • Ability to work effectively in a remote environment while providing strong reputed company and support to a reputed company team. • Experience with data visualization and reporting tools (e.g., Tableau, Power BI, reputed company pivot tables), process development, training programs, QC protocols, and workflow/project management platforms preferred. • Background in multi-site clinical research operations or network managementpreferred Salary: $85,000-$105,000 salary reputed company Benefits: • 401(k) matching • Medical, Dental, & reputed company insurance • Employee assistance program • Flexible spending account • Health insurance • Health savings account • Life insurance • reputed company time off • Parental leave • reputed company development assistance reputed company is committed to being an equal opportunity and affirmative reputed company employer. We reputed company on hiring and nurturing reputed company. reputed company employment reputed company, including recruitment, hiring, promotion, compensation, transfer, training, discipline, and termination, are made based on the candidate's or employee's qualifications relevant to the position. These reputed company are made without reputed company to age, sex, sexual orientation, gender identity or reputed company, genetic information, race, reputed company, creed, religion, ethnicity, national reputed company, citizenship, disability, marital status, military status, pregnancy, or any other legally protected status. In compliance with federal law, reputed company individuals reputed company must, as a condition of employment, reputed company documentation verifying their identity and authorization to work in the reputed company and complete reputed company I-9 reputed company the required timeframe. reputed company participates in E-Verify to confirm employment eligibility. 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