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Are you a seasoned professional in clinical research looking for a challenging role in a leading pharmaceutical company? Sun Pharma, one of the largest pharmaceutical companies in India, is hiring for the position of Clinical Research Associate (Team Member). This is a hybrid role based in Mumbai, offering a unique opportunity to work in a dynamic and innovative environment. Read on to learn more about the job responsibilities, qualifications, and how to apply.
Job Highlights: Clinical Research Associate at Sun Pharma
- Experience Required: 4–8 years in clinical trial operations
- Location: Mumbai (Hybrid Work Model)
- Key Skills: Risk-based monitoring, audits & inspections, GCP guidelines, clinical trial management
- Employment Type: Full Time, Permanent
- Education: B.Pharma, M.Pharma, B.Sc, or M.Sc in Life Sciences
Key Responsibilities of a Clinical Research Associate
As a Clinical Research Associate (Team Member) at Sun Pharma, you will play a pivotal role in managing clinical trials and ensuring compliance with regulatory standards. Here are the primary responsibilities:
1. CRO Managed Studies
- Manage Contract Research Organizations (CROs) for interventional, non-interventional, and epidemiological studies.
- Identify potential investigators and sites for clinical trials.
- Prepare and review clinical trial documents for Ethics Committee (EC) and Drugs Controller General of India (DCGI) submissions.
- Ensure timely reporting of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs).
- Train CROs on Sun Pharma’s Pharmacovigilance (PV) practices.
2. In-House Managed Studies
- Conduct site feasibility, investigator identification, and budget development.
- Execute Confidential Disclosure Agreements (CDAs) and study-related contracts.
- Oversee Investigational Product (IP) procurement, dispensing, and inventory management.
- Perform site monitoring, source data verification, and ensure compliance with Good Clinical Practice (GCP) guidelines.
- Coordinate with data management teams for query resolution and statistical analysis.
Who Can Apply?
Qualifications and Experience
- Education: B.Pharma, M.Pharma, B.Sc, or M.Sc in Life Sciences or related fields.
- Experience: 4–8 years in clinical trial operations within a CRO, Pharma, or Biotech organization.
- Skills:
- Thorough knowledge of ICH-GCP, New Drugs and Clinical Trial Rules (2019), and ICMR guidelines (2017).
- Experience in remote and risk-based monitoring.
- Proven track record in handling audits and inspections.
- Strong understanding of clinical trial methodologies and research design.
Preferred Skills
- Experience working in matrix business environments.
- Strong academic background with a focus on research methodologies.
- Excellent communication and stakeholder management skills.
Why Join Sun Pharma?
- Industry Leader: Sun Pharma is a globally recognized pharmaceutical company with a strong presence in over 100 countries.
- Employee-Centric Culture: Rated 4.0/5 by employees, Sun Pharma is known for its supportive work environment and focus on employee growth.
- Hybrid Work Model: Enjoy the flexibility of working from home and the office.
- Career Growth: Opportunities to work on cutting-edge clinical trials and advance your career in clinical research.
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