QC & Data Management Lead

About the Job

We are actively hiring a QC & Data Management Lead. This is a remote position. Shift: Monday-Friday (40 hours per week). Location: Remote- United States.

Purpose

Assure quality research data is collected by adhering to Flourish Standard Operating Procedures (SOPs), GCP, FDA, and protocol guidelines for all subject data that is submitted into the QC data entry department. Work closely with clinical research coordinators (CRCs) and ensure that the QC data entry department is utilizing the Punctual Accurate Complete True (P.A.C.T.) System. Assist clinical research associates (CRAs) during internal monitoring visits.

Essential Job Functions

• 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 the 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 (PSVs) and site initiation visits (SIVs).
• Attend manager meetings.
• Efficiently and effectively oversee the QC Data Entry department.
• Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors.
• Additional duties as assigned by management.

Physical Requirements and/or Environmental Factors

• Work is normally performed in a typical interior/office work environment.
• Local travel is required.
• Monitor/Sponsor customer service.
• Daily computer use.
• Ability to sit and/or stand for extended periods of time as work is performed on computer.
• Occasional evening and weekend work schedules.
• Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.
• Ability to drive and daily availability of an automobile.

Minimum Requirements

Education: Bachelor's degree or commensurate experience. Experience: Minimum of 2 years in the department plus 2 years in related role within the clinical research industry. Must have industry certification, as applicable.

Knowledge and Skills

• Consistently demonstrates core values & high proficiency in skills set.
• Must have the ability to understand medical terminology and research concepts.
• Must have the ability to identify appropriate subject care, relate in a professional and knowledgeable manner to physicians, pharmaceutical sponsors/CROs.
• Must have a basic knowledge of Good Clinical Practice (GCP), computer, internet, and Microsoft Office applications.
• Manage multiple tasks, ability to prioritize, meet deadlines, work independently, exercise initiative, demonstrate sound judgement, and consistently demonstrate effective oral and written communication.
• Develops and implements key initiatives in the department.
• Identifies and implements process improvements for increased efficiency.
• Builds and fosters relationships across teams.
• Consistently accomplishes 80% of individual goals each quarter.
• Serves as preceptor, mentor, and subject matter expert in the department.
• Demonstrates strong critical thinking and decision-making skills resulting in sound judgment.
• Flexible and able to multi-task and prioritize competing demands.
• Ability to think independently and influence when appropriate.