QC & Data Management Lead

🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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Flourish Research

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Pharmaceuticals

Flourish Research is a national, multi-site clinical trial network and site operator that runs paid clinical studies across the United States. It provides end-to-end clinical research solutions — from first-in-human and early in-patient Phase I studies through Phase II–IV trials — and partners with pharmaceutical sponsors and CROs to accelerate trial execution using wholly-owned sites, experienced investigators, recruitment technology, and access to diverse and underrepresented patient populations. The company operates dozens of clinic locations across many U. S. states, specializes in therapeutic areas including cardiometabolic, oncology, neuroscience, infectious disease and vaccines, and emphasizes patient-centric care, high retention, and regulatory-quality study delivery.

📋 Description

• Assure quality research data is collected according to Flourish SOPs, GCP, FDA, and protocol guidelines • Work closely with clinical research coordinators and ensure QC data entry uses the Punctual Accurate Complete True (P.A.C.T.) System • Assist clinical research associates during internal monitoring visits • Thoroughly review study charts using Flourish SOPs and sponsor-provided protocols • Enter data accurately into eCRF/CRF systems according to sponsor guidelines • Identify and report missing data, inconsistencies, discrepancies, and deviations • Create and approve source documents • Resolve open queries accurately and promptly • Assist during sponsor monitor visits to resolve queries • Oversee the quality and quantity of QC & Data Management Specialists' work • Conduct employee 1:1s and regular team meetings • Train new employees on QC/data-entry processes • Attend pre-study visits, site initiation visits, and manager meetings • Oversee the QC Data Entry department • Represent Flourish Research professionally when interacting with staff, clients, and vendors • Perform additional duties assigned by management

🎯 Requirements

• Bachelor's degree or commensurate experience • Minimum of 2 years in the department plus 2 years in a related role within the clinical research industry • Must have industry certification, as applicable • Ability to understand medical terminology and research concepts • Ability to identify appropriate subject care and relate professionally and knowledgeably to physicians and pharmaceutical sponsors/CROs • Basic knowledge of Good Clinical Practice (GCP), computers, the internet, and Microsoft Office applications • Ability to manage multiple tasks, prioritize, meet deadlines, work independently, exercise initiative, and demonstrate sound judgment • Effective oral and written communication • Ability to develop and implement key initiatives in the department • Ability to identify and implement process improvements for increased efficiency • Ability to build and foster relationships across teams • Ability to consistently accomplish 80% of individual goals each quarter • Ability to serve as preceptor, mentor, and subject matter expert in the department • Strong critical thinking and decision-making skills • Flexibility and ability to multitask and prioritize competing demands • Ability to think independently and influence when appropriate • Ability to drive and daily availability of an automobile • Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds

🏖️ Benefits

• Health, dental, and vision insurance plans • 401(k) with a 100% employer match on the first 4% of employee contributions • Tuition reimbursement • Parental leave • Employee referral program • Employee assistance program • Life insurance • Disability insurance • Generous PTO plan covering vacation, sick, personal days and 8 paid holidays