Macleods Pharmaceuticals Ltd. is inviting applications for the role of Clinical Research Associate (CRA) at its R&D III Centre in Mumbai.
This is an excellent opportunity for professionals with clinical trial monitoring experience and strong knowledge of ICH-GCP guidelines.
About Macleods Pharmaceuticals
Macleods Pharmaceuticals Ltd. is one of India’s leading pharmaceutical companies, known for its strong R&D focus and global presence. The company is committed to advancing healthcare through innovation and high-quality clinical research.
Job Details
- Company: Macleods Pharmaceuticals Ltd.
- Role: Clinical Research Associate (CRA)
- Department: Clinical Trials
- Location: Mumbai, Maharashtra
- Experience: Minimum 3 Years
- Qualification: B.Pharm, M.Pharm, Pharm.D, Life Sciences
- Work Mode: Work From Office
- Employment Type: Full-Time
Role Overview
As a CRA, you will manage end-to-end clinical trial monitoring activities, ensuring compliance with ICH-GCP, regulatory standards, and study protocols while coordinating with investigators and sites.
Key Responsibilities
- Conduct Site Selection Visits (SSV), Initiation (SIV), Monitoring (SMV), and Close-Out Visits (COV)
- Identify and evaluate clinical trial sites
- Prepare and review Ethics Committee submissions
- Ensure protocol compliance and regulatory adherence
- Review CRFs, source documents, and trial data
- Manage Trial Master File (TMF), SMF, and ISF
- Monitor AE & SAE reporting timelines
- Coordinate with investigators, vendors, and stakeholders
- Handle Investigational Product (IP) reconciliation
- Maintain study trackers and documentation
- Support SOP updates and process improvements
Required Qualifications
- B.Pharm / M.Pharm / Pharm.D
- BSc / MSc in Life Sciences
- Or equivalent qualification with Clinical Research experience
Experience Required
- Minimum 3 years of CRA experience
- Experience in clinical trial monitoring is mandatory
- ❌ Freshers are not eligible
Required Skills
- Clinical Trial Monitoring
- ICH-GCP Guidelines
- Site Management & Feasibility
- Regulatory Documentation
- CRF Review & Data Verification
- AE & SAE Reporting
- TMF / ISF Management
- Clinical Operations
- SOP Development
- Vendor & Stakeholder Coordination
Why Join Macleods?
- Work on regulated clinical trials
- Exposure to end-to-end clinical operations
- Growth in clinical research career path
- Experience with global GCP-compliant studies
- Collaborative and research-driven environment
How to Apply
Send your updated resume to:
adityab@macleodspharma.com
Subject Line:
Application for Clinical Research Associate – Mumbai
Important: Only candidates with relevant CRA experience will be considered. Freshers should not apply.
Job Location
- Mumbai, Maharashtra, India
Frequently Asked Questions
1. What experience is required?
A minimum of 3 years in Clinical Research Associate (CRA) role.
2. Is this role open to freshers?
No, only experienced candidates are eligible.
3. What guidelines should candidates be familiar with?
ICH-GCP and clinical trial regulatory standards.
4. What is the work mode?
Work from office (Mumbai location).
5. How to apply?
Send your resume via email with the correct subject line.
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