Description
Join Us in Shaping the Future of Clinical Research
Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromising data quality, safety, and diverse enrollment to advance healthcare. Our vision is to set the gold standard for clinical trial excellence. We believe our people make the difference. Guided by our core values—Scientific Rigor, Operational Excellence, Commitment to Sponsors and Participants, and Authentic Collaboration—we create an environment where meaningful work drives meaningful change.
At Adams Clinical, you’ll find:
- A culture of respect, transparency, and continuous improvement
- Opportunities for professional growth and learning
- A team dedicated to improving lives through innovation and integrity
If you’re passionate about making an impact in clinical research and want to be part of a collaborative, mission-driven organization, we’d love to have you on our team.
Job Role
Adams Clinical is a rapidly growing research site network specializing in late phase industry-sponsored trials of novel treatments for a variety of psychiatric and neurological conditions, supporting both inpatient and outpatient studies.
The Data Manager, Central Clinical Operations leads data management operations across Adams Clinical’s multi-site research network, ensuring data quality, integrity, and operational visibility across eSource and EDC platforms. This role oversees data governance processes, supports continuous improvement initiatives, and collaborates with eSource architects and operational teams to optimize source documentation workflows and data capture processes. By analyzing data quality 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 quality teams to support data review, audit readiness, database readiness, and timely issue resolution. This role establishes feedback loops between data findings and operational teams to identify training opportunities, improve source quality, and enhance consistency across clinical execution. The ideal candidate brings strong clinical research experience, data management expertise, and leadership skills to build scalable processes that support Adams Clinical’s growing research portfolio.
Key Responsibilities:
Team Leadership and Oversight
- Supervise, onboard, train, and manage 4–6 remote Data Entry Specialists, establishing clear expectations, competency standards, and performance metrics to ensure consistent data entry quality, protocol adherence, and timely completion of data capture activities across all sites.
- Develop standard operating procedures, workflows, and best practices for the data entry team.
- Provide ongoing performance management, feedback, and professional development opportunities through regular one-on-ones, team-level meetings and day-to-day touchpoints.
- Develop and maintain structured 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 enable visibility of data issues, quality gaps, and protocol deviations to site leadership and clinical operations management.
- Establish clear pathways for data issues to be flagged, triaged, assigned, and resolved with defined timelines and accountability.
Quality Control and Data Integrity
- Conduct quality control reviews of the first 3 subjects screened and first 3 enrolled at every Adams Clinical site, identifying data entry errors, protocol deviations, and inconsistencies.
- Build and document proactive QC processes that create clear standards, checklists, and assessment criteria for initial data reviews.
- Analyze QC findings, EDC queries, and data discrepancies to identify recurring trends, root causes, and opportunities for preventative action.
- Partner with site leadership and clinical operations teams to translate data findings into targeted retraining, process improvements, and updates to source documentation workflows.
- Identify patterns in source quality issues, documentation inconsistencies, and preventable queries to improve upstream clinical workflows and reduce downstream data corrections.
- Partner with Quality and Clinical Operations teams to support proactive audit readiness by monitoring data quality trends, identifying potential risks, ensuring timely remediation of data issues, and contributing to audit preparation activities ahead of sponsor audits, regulatory inspections, and internal quality reviews.
- Travel to sites as needed to support onboarding, training, workflow assessments, process improvement initiatives, and audit readiness activities, including collaboration with site teams during sponsor audits, regulatory inspections, and internal quality reviews.
EDC Management and Data Systems
- Maintain network-wide access and oversight of Adams Clinical data systems, working in CRIO eSource and sponsor EDC systems to identify and escalate system issues and user access needs.
- Stay current with EDC 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 all data management activities comply with FDA regulations, GCP guidelines, study protocols, and Adams Clinical data governance standards.
- Stay informed of regulatory changes affecting data management and ensure team compliance.
- Maintain availability during critical data or safety reporting windows (e.g., SAE reporting) that may require prompt attention outside standard business hours.
- Support continuous improvement of data governance practices by identifying opportunities to improve source quality, reduce preventable queries, and strengthen alignment between source documentation, eSource workflows, and EDC requirements.
Qualifications
- Bachelor's degree required.
- 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 integrity standards, and SUSAR/AE reporting.
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