Looking for Clinical Research Associate (CRA) jobs in Mumbai? Macleods Pharmaceuticals Ltd. is inviting applications for the position of Clinical Research Associate (CRA) at its R&D III Centre, Mumbai. This opportunity is ideal for experienced clinical research professionals with expertise in clinical trial monitoring, ICH-GCP, site management, regulatory documentation, TMF management, and clinical operations.
If you have 3 years of Clinical Research experience and are looking to build your career with one of India’s leading pharmaceutical companies, this is an excellent opportunity.
Job Details
| Particular | Details |
|---|---|
| Company | Macleods Pharmaceuticals Ltd. |
| Position | Clinical Research Associate (CRA) |
| Department | Clinical Trials |
| Location | Mumbai, Maharashtra |
| Experience Required | 3 Years |
| Work Mode | Work From Office |
| Employment Type | Full-Time |
Key Responsibilities
As a Clinical Research Associate (CRA) at Macleods Pharmaceuticals, you will be responsible for:
- Identifying and evaluating new clinical trial sites.
- Conducting site feasibility assessments.
- Performing Site Selection Visits (SSV).
- Conducting Site Initiation Visits (SIV).
- Performing routine Site Monitoring Visits (SMV).
- Executing Close-Out Visits (COV).
- Preparing and reviewing Ethics Committee (EC) submission dossiers.
- Coordinating translation and back-translation of study documents.
- Managing study initiation activities and site readiness.
- Training investigators and site staff according to protocol and ICH-GCP.
- Monitoring protocol compliance and regulatory adherence.
- Reviewing CRFs, source documents, and study documentation.
- Ensuring timely AE and SAE reporting.
- Resolving data discrepancies and maintaining data quality.
- Acting as the primary communication link between Macleods and study sites.
- Managing site budgets and payment milestones (if assigned).
- Updating study trackers and clinical trial documentation.
- Managing Trial Master File (TMF), Site Master File (SMF), and Investigator Site File (ISF).
- Handling Investigational Product (IP) reconciliation and clinical supplies.
- Preparing, reviewing, and updating departmental SOPs.
- Coordinating with internal and external stakeholders throughout the clinical trial lifecycle.
Required Qualifications
Candidates should possess:
- Bachelor’s Degree in Pharmacy (B.Pharm)
- Master of Pharmacy (M.Pharm)
- Pharm.D
- Master’s Degree in Life Sciences
- Other equivalent Life Science qualifications with relevant Clinical Research experience.
Experience Required
- Minimum 3 years of Clinical Research Associate (CRA) experience.
- Experience in clinical trial monitoring is mandatory.
- Freshers are not eligible.
Required Skills
- Clinical Trial Monitoring
- Site Selection & Feasibility
- Site Initiation Visits (SIV)
- Site Monitoring Visits (SMV)
- Close-Out Visits (COV)
- ICH-GCP Guidelines
- Clinical Trial Documentation
- Trial Master File (TMF)
- Investigator Site File (ISF)
- Site Management
- Regulatory Documentation
- Ethics Committee Submissions
- CRF Review
- AE & SAE Reporting
- Clinical Operations
- SOP Preparation
- Investigational Product (IP) Management
- Vendor Coordination
- Data Review & Query Resolution
Why Join Macleods Pharmaceuticals?
Macleods Pharmaceuticals is among India’s leading pharmaceutical companies with a strong focus on research and innovation. Joining the Clinical Trials team offers:
- Opportunity to work on regulated clinical studies.
- Exposure to end-to-end clinical trial operations.
- Professional growth in Clinical Research.
- Experience with GCP-compliant global studies.
- Collaborative R&D environment.
- Career advancement within one of India’s reputed pharmaceutical organizations.
How to Apply
Interested and eligible candidates can send their updated resume to:
Email: adityab@macleodspharma.com
Subject Line: Application for Clinical Research Associate โ Mumbai
Important: Freshers should not apply. Only candidates with relevant Clinical Research experience will be considered.