Senior Clinical Research Associate – Clinical Research | Clinexel | Navi Mumbai, Maharashtra, India

Clinexel is seeking experienced professionals for the position of Senior Clinical Research Associate at its clinical research operations in Navi Mumbai, Maharashtra, India. This full-time opportunity is ideal for candidates with 4 to 6 experience in clinical research and trial monitoring within the Pharmaceutical industry in India. The role focuses on managing clinical trial activities, monitoring investigator sites, ensuring compliance with regulatory guidelines, and maintaining the integrity of clinical data. The selected candidate will work closely with clinical operations teams, investigators, regulatory affairs professionals, and sponsors to ensure the successful execution of clinical trials. This position provides an excellent opportunity to contribute to innovative clinical research programs while supporting pharmaceutical and biotechnology organizations in bringing new therapies to patients. Professionals with strong knowledge of ICH-GCP guidelines and clinical trial management practices will be highly suitable for this role.

Location

Navi Mumbai, Maharashtra, India

Employment Type

Full-time

Experience Required

4 to 6

Compensation & Benefits

Salary range: 4 to 6 with opportunities to work on global clinical research projects and pharmaceutical development programs.

About Clinexel

Clinexel is a clinical research organization providing comprehensive clinical development services to pharmaceutical and biotechnology companies. The organization supports clinical trial design, regulatory compliance, data management, and monitoring services across multiple therapeutic areas.

Position Overview

The Senior Clinical Research Associate will be responsible for overseeing clinical trial sites, ensuring regulatory compliance, monitoring study progress, and maintaining high standards of clinical research quality.

Key Responsibilities

• Monitor clinical trial sites according to approved protocols.
• Ensure compliance with ICH-GCP and regulatory guidelines.
• Review clinical data and documentation for accuracy.
• Conduct site initiation, monitoring, and close-out visits.
• Coordinate with investigators and clinical site teams.
• Maintain clinical trial documentation and records.
• Report trial progress and deviations to sponsors.
• Support regulatory submissions and documentation.
• Assist in clinical study planning and execution.
• Ensure patient safety and ethical compliance.

Required Skills & Competencies

• Strong knowledge of clinical trial management.
• Understanding of ICH-GCP guidelines.
• Clinical data review and documentation expertise.
• Ability to coordinate with clinical research sites.
• Strong analytical and reporting skills.
• Excellent communication and presentation ability.
• Attention to detail and regulatory compliance awareness.
• Project coordination and time management skills.
• Problem-solving capability in clinical operations.

Educational Qualification

MPharm

About the Project & Industry

This role supports clinical research studies within the pharmaceutical and biotechnology sector, contributing to the development of new therapeutic treatments and regulatory submissions.

Why Join Clinexel?

Working with Clinexel offers the opportunity to participate in global clinical trials, collaborate with experienced research professionals, and contribute to innovative healthcare solutions.

How to Apply

careers@clinexel-cro.com