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Senior Clinical Data Manager
Precision For MedicineClinical Data Manager II overseeing clinical trial data management from startup to post-lock. Position requires extensive experience in clinical research organizations and related fields.
About the role
Key responsibilities & impact- Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects
- Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s)
- Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
- May perform quality control of data entry
- Provide input, assess and manage timelines
- May develop CRF specifications from the clinical study protocol
- Conduct database build UAT and maintain quality controlled database build documentation
- Responsible for creating, revising, appropriate versioning and maintaining data management documentation
- Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed
- Review and query clinical trial data according to the Data Management Plan
- Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
- Run patient and study level status and metric reporting
- Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
- Coordinate SAE/AE reconciliation
- Liaise with third-party vendors such as external data and EDC vendors
- Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies
- Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
- Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
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- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
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 developmentquality control of data entryCRF specifications developmentdatabase build UATmedical codingdata management documentationdata reviewdatabase migrationsdata management practices
Soft Skills
organizational skillscommunication skillsleadership skillsinterpersonal skillsproblem-solving skillsrepresentational skillstraining skillstimeline managementcollaboration skillsattention to detail