Responsibilities
- Lead, onboard, and train a team of 4–6 remote Data Entry Specialists, setting performance benchmarks and quality standards to ensure accurate, timely, and protocol-compliant data capture across all locations.
- Create and maintain standard operating procedures, workflows, and best practices tailored to the data entry function.
- Deliver consistent performance feedback and support professional growth through regular individual check-ins, team meetings, and daily interactions.
- Develop and update training materials, reference guides, and educational programs based on data trends, query analysis, protocol updates, and operational demands.
- Design and manage data escalation protocols to ensure timely identification and communication of data quality issues and protocol deviations to clinical leadership.
- Define clear processes for identifying, categorizing, assigning, and resolving data issues with accountability and time-based resolution targets.
- Perform quality control audits on the first three screened and first three enrolled subjects at each site to detect errors, inconsistencies, or non-compliance.
- Establish documented, proactive quality control procedures including standardized checklists and evaluation criteria for initial data reviews.
- Evaluate quality control results, EDC queries, and data discrepancies to detect patterns, determine root causes, and recommend preventive measures.
- Collaborate with site and clinical operations teams to convert data insights into retraining plans, workflow enhancements, and improvements to source documentation.
- Identify recurring issues in source data quality and documentation to refine upstream clinical processes and reduce avoidable data corrections.
- Work with Quality and Clinical Operations to ensure audit readiness by tracking data quality, flagging risks, resolving issues promptly, and supporting audit preparation.
- Travel to clinical sites as required to assist with onboarding, training, workflow evaluations, process optimization, and audit support activities.
- Maintain system-wide access to clinical data platforms, including CRIO eSource and sponsor EDC systems, to monitor usage and report technical or access issues.
- Stay informed about updates to EDC systems, regulatory requirements, and industry standards; deliver training on new features or protocol changes impacting data collection.
- Facilitate the integration of new data management technologies and tools as part of organizational growth and system upgrades.
- Support database lock procedures by coordinating data cleaning, tracking query resolution, monitoring entry completion, and escalating unresolved issues to relevant parties.
Team
- Team size: 4–6
- Structure: Reports to the Senior Manager, Central Clinical Operations.
Other
- Maintain availability during critical data or safety reporting windows (e.g., SAE reporting) that may require prompt attention outside standard business hours.
- Travel to sites as needed to support onboarding, training, workflow assessments, process improvement initiatives, and audit readiness activities.
