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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expert knowledge of Data Management processes and EDC data management systems, with a strong understanding of regulatory requirements and industry standards. Proven ability to lead cross-functional initiatives and manage vendor oversight in clinical studies.
Highest-signal resume keywords
Data Management ProcessesEDC Data Management SystemsRegulatory RequirementsStudy/Vendor OversightICH GCP Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementData Review and AnalysisDatabase Lock ActivitiesEdit Check SpecificationsUser Acceptance TestingCDISC SDTMCDASH21 CFR Part 11 ComplianceStatistical Analysis PlansClinical Protocol Review
Soft Skills
Excellent Communication SkillsOrganizational SkillsProblem Solving SkillsInterpersonal SkillsTime Management Skills
Tools & Technologies
Microsoft WordMicrosoft ExcelMedidata Rave EDCClinical Data Management SystemsCRO Management Tools
Industry Keywords
CROPharmaceuticalBiologicsBiotechnologyClinical Studies
About the role
Key responsibilities & impact- Contribute to data management activities supporting clinical studies across all stages of clinical drug development
- Lead cross-functional reviews of eCRF content and support eCRF development
- Support database build activities, including review of edit check specifications and user acceptance testing
- Monitor vendor data collection, coding, and cleaning through study metrics and targeted data reviews
- Oversee database lock activities and archive study data
- Collaborate with Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Drug Safety and Pharmacovigilance, CROs, laboratories, and other vendors
- Establish cross-functional internal data review plans, coordinate data cuts/transfers, and conduct data reviews
- Review CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications, and other study documentation
- Represent data management and communicate requirements, strategy, timelines, and deliverables in internal and external meetings
- Participate in drafting and/or reviewing timelines and ensure deliverables and milestones are met
- Review clinical protocols/amendments, clinical study reports, statistical analysis plans, and related documents
- Support GCP inspection readiness
- Demonstrate alignment with company values
- Perform other duties as assigned
Requirements
What you’ll need- BS/BA in scientific discipline required; MS or equivalent preferred
- At least 8 years related experience in a CRO/pharmaceutical/biologics/biotechnology company
- Study/Vendor oversight experience
- Experience with global studies, utilizing an outsourced CRO model
- Expert knowledge of Data Management processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
- Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH
- Experience working with EDC data management systems
- Understanding of ICH GCP as well as general knowledge of industry practices and standards
- Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
- Highly motivated and flexible, with excellent organizational and time management skills
- Ability to work independently and as part of a multi-disciplinary team
- Proficient in Microsoft Word and Excel
- Preferred: Experience working with Medidata Rave EDC
- Preferred: Experience using standardized medical terminology, including MedDRA and WHODrug
- Preferred: Prior experience working for both a Sponsor company and a CRO
- Preferred: Early phase clinical trial experience
- Excellent interpersonal and communications skills, verbal and written
- Problem solving and organization skills
- Proven ability to work independently
- Self-motivated, pro-active, and resourceful
- Strong ability to manage managers and/or individual contributors
- Excellent analytical and problem-solving skills
- Excellent communication skills with a diplomatic approach
- Excellent ability to lead cross-functional initiatives related to Data Management
- Demonstrated proactive thought process to minimize and mitigate risk independently
- Demonstrated ability to conduct root cause analysis cross-functionally in business problem solving and process improvement development
- Excellent presentation skills, internal and external
Benefits
Comp & perks- Full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position
- May involve travel