QC & Data Management Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure that high-quality research data is gathered in accordance with Flourish SOPs, GCP, FDA, and established protocol guidelines.

• Collaborate closely with clinical research coordinators to guarantee that quality control data entry adheres to the Punctual Accurate Complete True (P.A.C.T.) System.

• Support clinical research associates during internal monitoring visits.

• Conduct thorough reviews of study charts utilizing Flourish SOPs and protocols provided by the sponsor.

• Accurately input data into eCRF/CRF systems in line with sponsor guidelines.

• Identify and report any missing data, inconsistencies, discrepancies, and deviations.

• Create and approve source documents.

• Resolve open queries both accurately and promptly.

• Assist during sponsor monitoring visits to address queries.

• Supervise the quality and quantity of work performed by QC & Data Management Specialists.

• Hold regular one-on-one meetings with employees and team meetings.

• Provide training for new employees on QC/data-entry procedures.

• Participate in pre-study visits, site initiation visits, and manager meetings.

• Oversee the QC Data Entry department.

• Represent Flourish Research in a professional manner while interacting with staff, clients, and vendors.

• Undertake additional responsibilities assigned by management.

⛳️ Requirements

• Bachelor's degree or equivalent experience.

• A minimum of 2 years in the department plus 2 years in a related position within the clinical research field.

• Must possess relevant industry certification, as applicable.

• Capability to comprehend medical terminology and research concepts.

• Ability to identify appropriate subject care and engage professionally and knowledgeably with physicians and pharmaceutical sponsors/CROs.

• Fundamental knowledge of Good Clinical Practice (GCP), computer systems, the internet, and Microsoft Office applications.

• Capacity to manage multiple tasks, prioritize effectively, meet deadlines, work independently, demonstrate initiative, and exercise sound judgment.

• Proficient in both oral and written communication.

• Ability to develop and execute key initiatives within the department.

• Skill in identifying and implementing process improvements for enhanced efficiency.

• Capability to build and nurture relationships across teams.

• Ability to consistently achieve 80% of individual goals each quarter.

• Competence to serve as a preceptor, mentor, and subject matter expert in the department.

• Strong critical thinking and decision-making abilities.

• Flexibility to multitask and prioritize competing demands.

• Capacity to think independently and influence when appropriate.

• Access to a vehicle and daily availability for transportation.

• Ability to lift up to thirty-five pounds regularly and occasionally exceed that weight.

🏝️ Benefits

• Health, dental, and vision insurance plans.

• 401(k) plan with a 100% employer match on the first 4% of employee contributions.

• Tuition reimbursement program.

• Parental leave benefits.

• Employee referral program.

• Employee assistance program available.

• Life insurance coverage.

• Disability insurance options.

• Generous paid time off (PTO) plan covering vacation, sick, personal days, and 8 paid holidays.