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Clinical Data Manager II/Senior Clinical Data Manager
Precision For MedicineClinical Data Manager II/Senior managing clinical trial data processes at Precision for Medicine. Overseeing data management from study start to post database lock, ensuring quality and compliance.
About the role
Key responsibilities & impact- Responsible and manages all aspects of the clinical trial data management process
- Ensure that clinical data management deadlines are met with quality
- Oversee project data entry process including development of data entry guidelines
- Conduct database build UAT and maintain quality controlled database build documentation
- Perform quality control of data entry
- Train clinical research personnel on the study specific CRF
- Review and query clinical trial data according to the Data Management Plan
- Liaise with third-party vendors such as external data and EDC vendors in a project manager capacity
- Identify and troubleshoot operational problems and issues
- Participate in the development and maintenance of Standard Operating Procedures (SOPs)
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- Discretionary annual bonus
- Private medical insurance
- MultiSport Card
- Life insurance
- Pension
- Home working allowance
- Vacation
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 developmentdatabase build UATquality controlclinical research forms (CRF)data management plan reviewdatabase migrationsclinical database management systemsdrug developmentdata management practices
Soft Skills
organizational skillscommunication skillsinterpersonal skillsleadership skillsproblem-solving skillstraining skillsrepresentational skillsattention to detailtime managementteam collaboration