QC & Data Management Lead

About the role

Flourish Research is a progressive, diversified clinical trial organization with capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. The company strives for excellence, embraces diversity, and offers a supportive, collaborative work environment with comprehensive benefits and growth opportunities. The QC & Data Management Lead is a remote position (United States) working Monday‑Friday, 40 hours per week. Purpose: assure quality research data is collected by adhering to Flourish SOPs, GCP, FDA, and protocol guidelines; work closely with CRCs and ensure QC data entry uses the P.A.C.T. System; assist CRAs during internal monitoring visits.

Responsibilities

• Conduct a thorough and precise review of all study charts utilizing Flourish SOPs and sponsor‑provided protocols.
• Accurately enter data into an eCRF/CRF system according to sponsor‑provided eCRF/CRF guidelines in a timely manner.
• Identify and report any missing data points or inconsistencies to the CRC in a timely manner to ensure all data is clean and accurate.
• Source document creation/approval.
• Report any discrepancies between the source and CRF/eCRF immediately to the primary CRC and/or Team Lead.
• Notify Operations Leadership, Team Lead, and CRC of any major discrepancies and deviations in a timely manner.
• Resolve open queries thoroughly, accurately and in a timely manner.
• Assist in sponsor monitor visits to resolve queries in a timely manner.
• Perform all assigned duties in a timely‑ and cost‑effective manner.
• Actively learn and seek opportunities to expand expertise as a Lead, QC & Data Management.
• Oversee quality/quantity of QC & Data Management Specialists to ensure that all assigned tasks are completed accurately and in a timely manner.
• Perform employee 1:1s.
• Conduct regular team meetings.
• Train new employees regarding QC/DE processes.
• Attend pre‑study visits (PS