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Clinical Operations Lead(m/w/x)
Overseeing clinical project compliance, training, and assessment visits for CRAs. Undergraduate degree and 7-9 years related experience required; Health Sciences, Life Sciences, or Nursing background preferred. Occasional site travel.
Requirements
- College diploma/degree
- 7-9 years related experience
- Undergraduate university degree (Bachelors or Honors Bachelors)
- 4-6 years' experience
- Health Sciences, Life Sciences or Nursing specialty preferred
- SoCRA and/or ACRP Certification/Designation
- Minimum of 3 years CRA experience
- Strong experience with EDC systems
- Proficiency with MS Office
- Strong written and verbal communication skills
- Highly effective interpersonal and organizational skills
- Proactivity
- Detail orientation
- Task-driven
- Highly organized
- Understanding of GCPs and local regulations
- Clinical monitoring knowledge
- Ability in report writing
- Strong understanding of clinical research documents
- Ability to handle multiple tasks
- Ability to meet deadlines in a dynamic environment
Tasks
- Oversee clinical operations for projects
- Ensure compliance with study protocols and regulations
- Act as a liaison between CRAs and the clinical project team
- Provide project-specific training for CRAs
- Conduct assessment visits with CRAs
- Implement enrollment and recruitment strategies
- Prepare monitoring plans and structural documentation
- Schedule monitoring visits and track performance metrics
- Manage issue escalation and corrective actions
- Develop study tools for site and CRA use
- Review visit reports for quality and compliance
- Track protocol deviations
- Support clinical operations objectives
- Monitor regional CRA compliance with study timelines
- Conduct co-monitoring visits as needed
- Assist in vendor management activities
- Proactively manage site and country performance
- Contribute to financial project management processes
- Manage investigator sites temporarily or permanently
- Conduct regular global CRA calls
- Attend meetings with Study Sponsor for status updates
- Provide operational support to the monitoring team
- Train and mentor regional CRAs on study procedures
- Serve as the first point of contact for CRAs
- Liaise with line managers for CRA assignments
- Conduct CRA assessment visits to evaluate performance
- Develop training materials and study tools
- Create and present materials for Sponsor meetings
Work Experience
- 3 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Bonuses & Incentives
- Bonus
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Clinical Operations Lead(m/w/x)
Overseeing clinical project compliance, training, and assessment visits for CRAs. Undergraduate degree and 7-9 years related experience required; Health Sciences, Life Sciences, or Nursing background preferred. Occasional site travel.
Requirements
- College diploma/degree
- 7-9 years related experience
- Undergraduate university degree (Bachelors or Honors Bachelors)
- 4-6 years' experience
- Health Sciences, Life Sciences or Nursing specialty preferred
- SoCRA and/or ACRP Certification/Designation
- Minimum of 3 years CRA experience
- Strong experience with EDC systems
- Proficiency with MS Office
- Strong written and verbal communication skills
- Highly effective interpersonal and organizational skills
- Proactivity
- Detail orientation
- Task-driven
- Highly organized
- Understanding of GCPs and local regulations
- Clinical monitoring knowledge
- Ability in report writing
- Strong understanding of clinical research documents
- Ability to handle multiple tasks
- Ability to meet deadlines in a dynamic environment
Tasks
- Oversee clinical operations for projects
- Ensure compliance with study protocols and regulations
- Act as a liaison between CRAs and the clinical project team
- Provide project-specific training for CRAs
- Conduct assessment visits with CRAs
- Implement enrollment and recruitment strategies
- Prepare monitoring plans and structural documentation
- Schedule monitoring visits and track performance metrics
- Manage issue escalation and corrective actions
- Develop study tools for site and CRA use
- Review visit reports for quality and compliance
- Track protocol deviations
- Support clinical operations objectives
- Monitor regional CRA compliance with study timelines
- Conduct co-monitoring visits as needed
- Assist in vendor management activities
- Proactively manage site and country performance
- Contribute to financial project management processes
- Manage investigator sites temporarily or permanently
- Conduct regular global CRA calls
- Attend meetings with Study Sponsor for status updates
- Provide operational support to the monitoring team
- Train and mentor regional CRAs on study procedures
- Serve as the first point of contact for CRAs
- Liaise with line managers for CRA assignments
- Conduct CRA assessment visits to evaluate performance
- Develop training materials and study tools
- Create and present materials for Sponsor meetings
Work Experience
- 3 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Bonuses & Incentives
- Bonus
About the Company
Alimentiv
Industry
Healthcare
Description
Alimentiv provides project management teams in Full-Service Study Management, Imaging, and Corporate Services.
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