Clinical Operations Lead (Clinical Trial Manager) (India)

1 month ago
Full-time
Senior
Project and Program Management
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

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

Similar Roles

Access and Stewardship Program Director

onXmaps 251-1K Food Products

onX is hiring an Access & Stewardship Program Director to lead its mission-driven program connecting public lands stewardship, customer education, government relations, and partnerships with the company’s outdoor products and brand priorities.

4 hours, 58 minutes ago

Senior Technical Program Manager

Coforge 10K-50K IT Services

Coforge is hiring a Senior Technical Program Manager in a remote role to lead cross-functional technology programs and drive execution, launch readiness, and measurable delivery outcomes.

Agile
5 hours, 28 minutes ago

Lead Program Manager, Global SMB Sales Enablement

Pinterest 5K-10K Internet Software & Services

Pinterest is hiring a Lead Global Program Manager for Sales Enablement to shape global SMB sales enablement programs, systems, and operating rhythms that support seller onboarding, learning, and readiness.

Salesforce Tableau
5 hours, 43 minutes ago

Interconnection Strategy Lead

Mainspring Energy 251-1K Renewable Electricity

Mainspring Energy is hiring an Interconnection Strategy Lead to build scalable utility and interconnection strategy for complex, larger-scale power projects and customer deployments across North America.

JIRA System Design
5 hours, 43 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers