Required Team Leader for Clinical Trial Operations @ Vimta Labs Ltd, Cherlapally, Hyderabad.

Immediate Joiners are prefered.

Job Description

Team Leader Clinical Trial Operations

Position Summary

The Team Leader – Clinical Trial Operations is responsible for leading and managing clinical operations activities across multiple clinical trials, ensuring high standards of quality, regulatory compliance, and timely study execution. The role involves direct oversight of CRAs and CTAs, handson site monitoring, crossfunctional coordination, and preparation for audits and inspections.

Key Responsibilities

Team Leadership & Management

- Lead, mentor, and oversee the performance of CRA, Senior CRA, and CTA teams to ensure effective execution of clinical trial activities.
- Provide guidance, training, performance feedback, and issue resolution to team members.
- Ensure appropriate resource allocation and workload management across studies.

Clinical Trial Monitoring

- Perform independent site monitoring or comonitoring for patientbased clinical trials across multiple therapeutic areas.
- Ensure adherence to study protocols, ICHGCP guidelines, regulatory requirements, and sponsor SOPs.
- Identify, escalate, and support resolution of sitelevel risks, deviations, and quality issues.

Quality & Compliance

- Perform Quality Control (QC) reviews of regulatory documents and Trial Master Files (TMF/eTMF) to ensure inspection readiness.
- Support the development, review, and implementation of SOPs, Working Practice Documents (WPDs), and system-related documents.
- Prepare the department and organization for internal audits, sponsor audits, regulatory inspections, and other quality assessments.

Feasibility, Site Identification & Selection

- Conduct trial feasibility assessments, site identification, and Site Selection Visits (SSVs).




- Evaluate site capabilities, patient availability, infrastructure, and regulatory readiness.
- Support site activation and ongoing site relationship management.

Contracts & Vendor Coordination

- Assist in the preparation and review of Clinical Trial Agreements (CTA), MOUs, and other study-related contracts with sponsors and vendors.
- Coordinate with legal, finance, and procurement teams to facilitate timely contract execution.
- Support vendor selection, coordination, and performance monitoring as required by the study.

CrossFunctional Collaboration

- Work closely with Data Management, Finance, Procurement, Vendors, and other internal stakeholders to ensure seamless study execution.
- Demonstrate robust negotiation, communication, and data analysis skills to support operational decisionmaking.
- Participate in crossfunctional meetings and project reviews.

Travel & Field Support

- Willing to travel locally and outstation as per project requirements, including site visits, audits, and investigator meetings.

Qualifications & Experience

- 8-12 years of relevant experience in Clinical Operations within a CRO, pharmaceutical company, or clinical research organization.
- Proven experience in clinical trial monitoring, team leadership, quality management, and audit readiness.
- Strong knowledge of ICHGCP, regulatory requirements, and the clinical trial lifecycle.
- Excellent organizational, interpersonal, and stakeholder management skills.

Key Competencies

- Leadership and team management
- Clinical trial monitoring and execution
- Regulatory compliance and quality assurance
- Feasibility assessment and site management
- Crossfunctional collaboration
- Communication and negotiation skills
- Problemsolving and analytical thinking

Interested candidates can share their profiles to [email protected]

Contact:

Keerthana

(phone hidden)

📌 Team Lead in Clinical Trials @ Vimta Labs Ltd, Hyderabad
🏢 Vimta Labs
📍 Hyderabad