Clinical Operations Lead – Clinical Trial Manager

This is a fully remote position, open to applicants in India.

📋 Description

• Accountable for managing the clinical operations of a project at a specified regional or global level.

• Ensures oversight of project deliverables, assigned Clinical Research Associates (CRAs), and Investigator sites.

• Acts as the main point of contact between the CRAs and the clinical project team.

• Additional duties include providing project-specific training for CRAs and conducting assessment visits with them.

• Responsible for the execution of enrollment and recruitment strategies, the preparation of the monitoring plan, and other essential documentation.

• Oversees the scheduling of monitoring visits, site performance metrics, issue escalation, and corrective actions.

• Develops study tools for use by sites and CRAs, reviews visit reports, and tracks protocol deviations.

• Assists with other objectives related to clinical operations and the clinical project team.

⛳️ Requirements

• College diploma or degree AND 7-9 years of relevant experience along with continuous training and skills enhancement.

• OR an undergraduate degree (Bachelor's or Honors Bachelor's) AND 4-6 years of experience with significant ongoing job-related training.

• Preferred specialties include Health Sciences, Life Sciences, or Nursing, or possession of SoCRA and/or ACRP Certification/Designation.

• Must have a minimum of 3 years of CRA experience, strong proficiency with EDC systems, and be skilled in MS Office, with excellent written and verbal communication abilities along with effective interpersonal and organizational skills.

• Should exemplify the following traits: proactive, detail-oriented, task-driven, and highly organized.

• Must demonstrate a strong understanding of GCPs and local regulations concerning clinical monitoring, IRB/EC, and Investigator responsibilities.

• Proven ability in report writing and a strong capacity to critically analyze clinical research documents.

• Capable of managing multiple tasks to meet deadlines in a fast-paced environment.

🏝️ Benefits

• Accommodations for individuals with disabilities are available upon request throughout all phases of the recruitment and selection process.

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