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Senior Clinical Data Manager
Precision Medicine Group. Manage all aspects of the clinical trial data management process from study start-up through post-database lock for assigned projects .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trial data processes, including database management, quality control, and regulatory compliance. Proficient in training personnel and communicating effectively with stakeholders to ensure project success.
Highest-signal resume keywords
Clinical Data ManagementDatabase Management SystemsCDISC StandardsMedical CodingLeadership Skills
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 Data ManagementQuality ControlCRF Specifications DevelopmentSAS ProgrammingData Management DocumentationData ReviewEdit-Check SpecificationsDatabase Build UATMetric ReportingRegulatory Compliance
Soft Skills
Organizational SkillsCommunication SkillsInterpersonal SkillsLeadership SkillsTraining Skills
Tools & Technologies
Microsoft OfficeEDC SystemsClinical DatabasesTrial Master FileData Management SOPs
Industry Keywords
Clinical ResearchOncologyOrphan Drug DevelopmentDrug DevelopmentBiologic DevelopmentMedDRAWHODrugCDASHSDTMADaM
About the role
Key responsibilities & impact- Manage all aspects of the clinical trial data management process from study start-up through post-database lock for assigned projects
- Follow Standard Operating Procedures, Work Instructions, regulatory directives, study-specific plans and guidelines
- Serve as primary Data Management contact and Lead Data Manager for assigned clinical projects/programs
- Oversee project data entry processes, including guidelines, training, quality and resourcing
- Perform quality control of data entry as needed
- Assess and manage timelines, deadlines and resource needs
- Develop CRF specifications from clinical study protocols and coordinate stakeholder review
- Assist with building clinical databases
- Conduct database build UAT and maintain quality-controlled database documentation
- Oversee clinical database quality
- Specify and oversee edit-check and manual data-review specifications
- Create, revise, version and maintain data management documentation and Trial Master File completeness
- Train clinical research personnel on study-specific CRFs, EDC and related project materials
- Review and query clinical trial data according to the Data Management Plan
- Perform line-listing data review and patient/study status and metric reporting
- Perform medical coding and coordinate SAE/AE reconciliation
- Manage third-party data and EDC vendors in support of timelines and data deliverables
- Assist with SAS programming and quality control of SAS programs
- Identify and troubleshoot operational problems using metrics, audit reports and stakeholder input
- Review and provide feedback on protocols, SAPs and CSRs as required
- Participate in developing and maintaining data management SOPs and process documentation
- Participate in strategy meetings, bid-defense preparation, capability presentations and client engagement meetings
- Review RFPs, proposals and provide project estimates
- Provide leadership for cross-functional and organization-wide initiatives
- Train and ensure data management project team members are sufficiently trained
- Communicate with sponsors, vendors and project teams regarding data, database and project issues
- Present software demonstrations, trainings and project meetings
- Travel occasionally as required
- Perform other assigned duties
Requirements
What you’ll need- Bachelor's degree and/or a combination of related experience
- 8+ years’ experience as a Clinical Data Manager
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- Ability to handle a variety of clinical research tasks
- Excellent organizational and communication skills
- Professional use of the English language, both written and oral
- Experience utilizing various clinical database management systems
- Broad knowledge of drug, device and/or biologic development and effective data management practices
- Strong representational skills and ability to communicate effectively orally and in writing
- Strong leadership and interpersonal skills
- Ability to undertake occasional travel
- Experience in a clinical, scientific or healthcare discipline preferred
- Dictionary medical coding (MedDRA and WHODrug) preferred
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.) preferred
- Oncology and/or Orphan Drug therapeutic experience preferred
- Candidates must be legally authorized to work in the country of employment without employer sponsorship
Benefits
Comp & perks- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Parental leave
- Paid time off for sick leave and vacation
- Reasonable accommodation for applicants with disabilities