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Clinical Operations Lead (Clinical Trial Manager) (India)

1 month, 4 weeks ago
India
Full-time
Senior
Program Manager
Project and Program Management
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986
View All Jobs 27

Description

  • Oversee regional CRAs and investigator sites to ensure compliance with study protocols, monitoring plans, ICH-GCP, local regulations, and timelines.
  • Serve as the primary liaison between CRAs and the clinical project team.
  • Provide project-specific training, mentoring, and operational guidance to regional CRAs.
  • Conduct CRA assessment visits and co-monitoring/support visits as required.
  • Prepare, implement, and maintain monitoring plans, study tools, training materials, and other study documentation.
  • Develop and support enrollment and recruitment strategies with the clinical project team.
  • Review visit reports, track protocol deviations, and escalate issues with corrective actions as needed.
  • Monitor site, country, and CRA performance metrics, including recruitment, data collection, document collection, and TMF review.
  • Support regional startup, feasibility, and vendor management activities as required.
  • Assist with sponsor meetings, kickoff meetings, investigator meetings, and site qualification/initiation visit presentations.

Requirements

  • College diploma/degree plus 7-9 years of related experience and continuous training, or an undergraduate degree plus 4-6 years of experience and substantial ongoing job-related training.
  • Health Sciences, Life Sciences, or Nursing specialization preferred.
  • SoCRA and/or ACRP certification/designation preferred.
  • Minimum 3 years of CRA experience.
  • Strong experience with EDC systems.
  • Proficiency with MS Office.
  • Strong written and verbal communication skills.
  • Highly effective interpersonal, organizational, and report-writing skills.
  • Demonstrated understanding of GCPs, local regulations, IRB/EC requirements, and investigator responsibilities related to clinical monitoring.
  • Ability to handle multiple tasks and meet deadlines in a dynamic environment.

Benefits

  • Home-based working arrangement.
  • Accommodations for persons with disabilities are available on request.
  • Employer-provided support throughout the recruitment and selection process.

Interested in this position?

Apply directly on the company website

Apply Now

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