Clinical Data Manager

Accountabilities:: Clinical data collection and CRF development: Collaborate with key stakeholders to identify and define the appropriate data elements for clinical research. Develop and manage Case Report Forms (CRFs) for both pre-market and post-market clinical studies. Database development and vendor coordination: Serve as the primary liaison with database vendors to support database development and ensure accurate implementation of CRFs according to approved specifications. User Acceptance Testing: Perform User Acceptance Testing (UAT) for new database builds and updates to existing systems. Develop methods to improve and standardize testing processes and coordinate feedback to database vendors. Data management planning: Draft and maintain Data Management Plans (DMPs) and Data Review Plans for pre-market and post-market studies. Data quality and review: Oversee the quality of clinical data collection, including defining data queries in advance and identifying additional queries during study execution. Support discrepancy management and ongoing data quality review. Data Science collaboration: Work with the Data Science team during formal statistical analyses to improve data accuracy and strengthen related processes. Clinical metrics: Collaborate with internal stakeholders to develop clinical metrics for both internal and external use. Database lock and regulatory readiness: Coordinate and ensure timely database locks in preparation for clinical reporting and regulatory submissions. Audit support: Provide assistance with internal and external audits as required. Requirements: Bachelor's degree in a scientific discipline. At least 5 years of experience working with medical device clinical studies. Knowledge and practical experience with Good Clinical Practice (GCP), ICH guidelines, GDPR, and FDA and EU regulatory environments. Understanding of clinical data management (CDM) standards for medical devices; pre-market clinical study experience is preferred. Strong expertise in developing, validating, and managing clinical study databases. Experience across the clinical data management software lifecycle, including CRF design, database development and testing, discrepancy management, data quality review, data analysis, and final database archival. Experience as a Clinical Research Associate (CRA), or in developing, validating, or administering clinical systems for data collection or clinical data analysis, is an advantage. Excellent written and verbal communication skills. Strong analytical, critical-thinking, and problem-solving abilities, including the capacity to interpret and analyze clinical data. Demonstrated collaboration, leadership, and relationship-building skills, with the ability to work effectively with internal and external stakeholders. Strong organizational skills and the ability to prioritize multiple tasks, manage deadlines, and ensure consistent follow-through. Ability to translate strategic plans into practical operational objectives. Flexibility and resilience when managing shifting priorities in a fast-paced environment, while maintaining clear communication with colleagues and management. Proficiency in Microsoft Office, particularly Word and PowerPoint. Ability to work effectively in a remote environment and willingness to travel up to 10% of the time, including occasional day trips, overnight stays, and visits to local sites or meetings. Ability to lift up to 20 pounds and work at a computer for extended periods, including approximately 8 hours per day. Benefits: Annual salary range of $105,000–$130,000. Health, dental, and vision insurance. Life insurance. Short-term and long-term disability insurance. 401(k) retirement plan. Paid time off. Additional benefits included in the comprehensive full-time employee benefits package.