Clinical Data Manager (Hybrid)

Trifecta Proven delivers comprehensive, compliant, and mission-focused healthcare staffing and program support tailored to the unique demands of government and military environments. We combine deep industry expertise with a disciplined, results-driven approach to ensure every placement and every program meet the highest standards of quality, readiness, and accountability. Trifecta Proven is recruiting for Clinical Data Managers (CDMs) to provider services at the National Institute of Health. There are multiple openings available. We are looking for Level I, II and II CDMs. They will support the National Heart, Lung and Blood Institute Clinical Trials. Work Hours: Monday through Friday between the hours of 7:30 a.m. and 6:00 p.m. Will work an eight hour shift. Duties: Research Data-related Activities: Gather and enter protocol data into databases according to the specific needs of each protocol Develop and structure protocol-specific data management processes Abstract and grade Adverse Events • Run scheduled and ad-hoc reports for Research Teams Prepare data/reports for routine audits from clinical research monitors Prepare data/reports for audits from regulatory agencies and sponsors Participate in the reconciliation of data discrepancies identified in monitoring visits and audits Participate in the clinical research team meetings Assist with monitoring activities Prepare for and assist with site monitoring visits (SMVs) Assist clinical research teams with resolution of monitor queries Prepare responses to SMV report data queries 2. Quality-Assurance Responsibilities Provide data management processes overview to new clinical teams Conduct three-step CDM Quality Control process Coordinate with clinical research team to ensure timelines of data reporting and compliance wit hthe protocol 3. Center for International Blood & Marrow Transplant Research (CIBMTR) Data Management Collect transplant data Reconcile transplant data discrepancies Perform data abstraction/entry and submission to CIBMTR Coordinate activities in various transplant groups to ensure compliance with Continuous Process Improvement timelines Assist with development of sourc document templates Provide CIBMTR data traing to new clinical research team members 4. Database-related activities Enter data into databases specific to each protocol • Assist with eCRF development Assist with the development and maintenance of clinical databases including but not limited to NIH’s CTDB and other sponsor databases Assist with database user acceptance testing Coordinate activities related to active database support (i.e. amendments, technical updates, etc.) 5. CDMs shall be considered Intengrated members of the lcinical research teams to which they have been assigned. Qualifications: Education: Bachelor of Science in life sciences, health informatics, statistics, nursing, biomedical engineering, or related field; MS in clinical research/biostatistics/health data science preferred for lead roles. Experience: Shall have a minimum of two years of experience. Five years of experience required for lead roles. Experience providing services at NIH is a plus. Certification: Certified Clinical Data Manager by the Society for Clinical Data Management is preferred. Knowledge: Strong understanding of Good Clinical Data Management Practices (GCDMP). Trifecta Proven, LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, sexual orientation, gender identity, or any other protected characteristic under applicable law. Employment Type: Full Time Years Experience: 1 - 3 years Salary: $80,110 - $152,240 Annual Bonus/Commission: No