Clinical Operations Specialist

Why This Role Matters
The Clinical Operations Specialist – Medical Writing plays a critical role in supporting clinical research projects by ensuring accurate documentation and compliance with regulatory standards. The position contributes to maintaining high-quality clinical research outputs by preparing protocols, study reports, and regulatory documents while ensuring adherence to Good Clinical Practice and international guidelines.

Job Description
The Clinical Operations Specialist will manage clinical research activities while handling medical writing responsibilities related to clinical trials. The role involves preparing and reviewing clinical documentation, coordinating with cross-functional teams, and supporting regulatory submissions to ensure successful execution of clinical research projects.

Key Features of the Role
• Opportunity to work in a Contract Research Organization (CRO) environment
• Exposure to clinical research operations and medical writing
• Involvement in preparation of clinical study reports and regulatory documentation
• Collaboration with clinical research, data management, and biostatistics teams
• Professional growth opportunities in clinical research and regulatory documentation

Responsibilities
• Oversee clinical research projects from initiation to completion while ensuring regulatory compliance
• Develop, review, and edit clinical study protocols, informed consent forms, and study reports
• Prepare and manage essential clinical trial documentation
• Coordinate with cross-functional teams including clinical research associates, data managers, and biostatisticians
• Maintain knowledge of regulatory guidelines and industry best practices
• Coordinate with external vendors and stakeholders to meet project milestones
• Support preparation and submission of regulatory documents to health authorities
• Maintain proper documentation and archiving of clinical study materials
• Provide guidance and mentorship to junior staff on clinical operations and medical writing

Required Qualifications

Educational Requirements:
• Bachelor’s Degree in Life Sciences, Pharmacy, or a related field
• Master’s or PhD in a relevant discipline preferred

Experience and Skills:
• 4–10 years of experience in clinical operations or medical writing in the pharmaceutical or CRO industry
• Strong knowledge of clinical trial documentation and regulatory processes
• Understanding of Good Clinical Practice (GCP) and ICH guidelines
• Strong medical writing and documentation skills
• Excellent coordination, communication, and analytical abilities

Salary Insights:
• ₹35,000 – ₹80,000 per month (approx.)

Company Overview
Micro Therapeutic Research Labs Pvt Ltd is a quality-driven Contract Research Organization (CRO) providing clinical research services to global pharmaceutical, biotechnology, nutraceutical, and cosmetic industries. The company specializes in bioavailability and bioequivalence studies and offers comprehensive research support to healthcare and pharmaceutical organizations.

FAQs
• What qualification is required for this role?
Candidates should have a Bachelor’s degree in Life Sciences, Pharmacy, or a related field. Advanced degrees may be preferred.

• What experience is required?
Candidates should have 4–10 years of experience in clinical operations or medical writing within the pharmaceutical or CRO sector.

• Where is the job located?
The position is based in Selaiyur, East Tambaram, Chennai, Tamil Nadu, India.

• What salary is offered for this role?
The expected salary ranges between ₹35,000 and ₹80,000 per month.

Application Tips
• Highlight experience in clinical trial documentation and medical writing
• Mention knowledge of GCP, ICH guidelines, and regulatory processes
• Showcase experience working in pharmaceutical or CRO environments
• Emphasize project coordination and cross-functional collaboration skills
• Include examples of clinical reports, protocols, or regulatory documents handled in previous roles