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Clinical Data Manager II – Senior Clinical Data Manager
Precision Medicine GroupClinical Data Manager responsible for managing clinical trial data processes and ensuring data integrity. Requires extensive experience in clinical data management within a pharma or biotech setting.
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 managementdata entry guidelines developmentCRF specifications developmentdatabase build UATedit check specificationsSAE/AE reconciliationdatabase migrationsclinical database management systemsdata management practicesmetrics data analysis
Soft Skills
organizational skillscommunication skillsinterpersonal skillsleadership skillsproblem-solving skillstraining skillsstakeholder managementtime managementrepresentational skillsteam collaboration
Tools & Technologies
Microsoft Officeclinical database management systemsdata management softwareproject management toolsreporting toolsdata visualization toolselectronic data capture systemsstatistical analysis softwarequality control systemscollaboration platforms
Industry Keywords
clinical researchpharmaceuticalbiotechoncologydata management planclinical project managementregulatory compliancedrug developmentbiologic developmentclinical trial protocols
About the role
Key responsibilities & impact- Responsible for managing all aspects of the clinical trial data management process from study start up to post database lock
- Primary Data Management (DM) contact for assigned clinical project(s), ensuring continuity and timely task performance
- Oversee project data entry process including development of data entry guidelines, training, and quality
- Provide input, assess and manage timelines to ensure clinical data management deadlines are met
- Develop CRF specifications from clinical study protocols and coordinate feedback from stakeholders
- Conduct database build UAT and maintain quality controlled database build documentation
- Specify requirements for all edit check types and oversee the development of specifications
- Train clinical research personnel on project related items
- Review and query clinical trial data according to the Data Management Plan
- Run patient and study level status and metric reporting
- Coordinate SAE/AE reconciliation
- Liaise with third-party vendors in a project manager capacity
- Identify and troubleshoot operational problems based on metrics data
Requirements
What you’ll need- Bachelors and/or a combination of related experience
- 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company
- Set up and Database migrations experience
- Oncology experience preferred
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- Excellent organizational and communication skills
- Professional use of the English language; both written and oral
- Experience in utilizing various clinical database management systems
- Broad knowledge of drug, device and/or biologic development and effective data management practices
- Strong representational skills, ability to communicate effectively orally and in writing
- Strong leadership and interpersonal skills
- Ability to undertake occasional travel
Benefits
Comp & perks- Work from home opportunities
- Flexible work arrangements