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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.
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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
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