Clinical Data Lead, Digital Trial Solutions
Reporting to the SVP, Digital Trial Solutions (DTS), the Clinical Data Lead oversees the data curation data maintenance activities for the DTS study portfolio. Job activities include reviewing and providing feedback on project curation specifications and instructions, tracking data quality and quantity for DTS studies, identifying staffing needs to complete projects on time, and other project-related activities as assigned. The Clinical Data Lead navigates electronic medical record systems and other medical databases, leads the abstraction of medical record data related to study requirements, and functions as the Subject Matter Expert (SME) for clinical data abstraction services. The Clinical Data Lead will work closely with all other members of DTS management to ensure deadlines are met and that procedures are followed to maintain the integrity of DTS clinical data service.
- Lead the Clinical Data Abstraction services for all DTS projects.
- Coordinate with DTS leadership to ensure study timelines are achieved.
- Review and provide feedback on project specific documents.
- Develop familiarity with project goals to be able to provide expert feedback to members of the DTS data team working on that project.
- Create and conduct, or oversee, the development of the curation specifications and training for DTS studies.
- Coordinate with the DTS management team to discuss curation errors, queries, and resolutions that will be used to develop Continuous Quality Improvement (CQI) plans for each project.
- Interact internally with the other data abstractors in DTS and across the company to ensure consistency in processes (where required)
- May interact with scientific or medical staff for guidance on medical issues and interpretation of medical record data.
- Other duties, as assigned, including review of selected medical records to assess eligibility for new projects.
- Maintain a professional approach respecting the dignity and confidentiality of associates, managers, and vendors.
- Bachelors degree.
- Clinical or research experience in the field of Oncology from a CRO, pharmaceutical, or clinical trial technology company.
- 3+ years’ experience abstracting clinical data from electronic systems and other sources.
- Experience with medical records, data abstraction, chart audit, and coding is required.
- Management or supervisory experience preferred.
- Must have excellent critical thinking, supervisory, organizational, and time management skills.
- Flexibility in coping with changing work assignments, changing project requirements, varying training meeting schedules, and database resources that may not always function optimally.
- Computer skills are required, as 90% of work activity involves working with a computer. Comfort with technology, and willingness to learn new software programs is highly desirable.
- The ability to make independent judgments in abstracting medical data and the knowledge of when to seek input from other staff.
- The ability to cope with incomplete medical record data, and problem solve to find required information.
- Highly proficient with MS Office, project management software.