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QC & Data Management Lead
Flourish Research. Assure quality research data is collected according to Flourish SOPs, GCP, FDA, and protocol guidelines .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research data management, ensuring compliance with GCP, FDA, and protocol guidelines while effectively training and overseeing team members. Proficient in data entry processes and quality control, with strong communication and critical thinking skills to enhance departmental efficiency.
Highest-signal resume keywords
Clinical Research ExperienceGood Clinical Practice (GCP)Data ManagementQuality Control (QC)Effective Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data EntryECRF/CRF SystemsMedical TerminologyResearch ConceptsProcess Improvement
Soft Skills
Critical ThinkingDecision-MakingMentoringRelationship BuildingMultitasking
Tools & Technologies
Microsoft OfficeP.A.C.T. System
Certifications & Qualifications
Industry Certification
Industry Keywords
Clinical ResearchSOPsSponsor GuidelinesData QualityTeam Management
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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