Sun Pharma Hiring Clinical Research Associates in Mumbai – Apply Now
Organization: Sun Pharma Laboratories Ltd
Position: Clinical Research Associate
Location: Mumbai, India
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Experience: 4-5 years
Salary: ₹45,000 – ₹65,000 per month
About Sun Pharma
Sun Pharma Laboratories Ltd, a leading global pharmaceutical company, is seeking a Clinical Research Associate (CRA) to join our dynamic team. Based at the Sun House Corporate Office in Mumbai, this role is critical in managing and overseeing clinical trials that contribute to the development of innovative healthcare solutions.
Key Responsibilities
Study Preparation & Execution
- Site Feasibility & Investigator Identification: Conduct feasibility studies, identify potential investigators, and develop study budgets.
- Investigator & Site Finalization: Finalize investigators and sites, execute Confidential Disclosure Agreements (CDAs), and manage study-related contracts.
- Investigator Meetings: Plan and conduct Investigator Meetings when necessary.
- Ethics Committee Approvals: Prepare and submit study documents for Ethics Committee (EC) approval.
Site Management
- Trial Supply Logistics: Facilitate Investigational Product (IP) procurement and ensure smooth logistics.
- IP Management: Oversee and document IP dispensing, inventory management, and reconciliation.
- Site Activities: Perform site initiation, monitoring, and close-out activities.
- Training: Train investigators and site personnel on study protocols, procedures, and Good Clinical Practice (GCP) principles.
Data Management & Compliance
- Participant Recruitment: Ensure efficient recruitment of trial participants and effective data management.
- Site Monitoring: Conduct regular site monitoring visits to review source data, informed consent forms, and case report forms for accuracy and compliance.
- Safety Reporting: Ensure timely reporting of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), complying with regulatory and company pharmacovigilance policies.
Coordination & Reporting
- Project Meetings: Coordinate project meetings and prepare monitoring visit reports.
- Budget Management: Manage trial budgets and maintain accounts.
- Collaboration with CROs: Coordinate with Contract Research Organization (CRO) partners for data management and statistical analysis.
- Data Query Resolution: Lead and guide the resolution of data queries.
Risk & Quality Management
- Risk Identification & CAPA: Identify risks, analyze them, and implement Corrective and Preventive Actions (CAPAs) for sites not meeting expectations.
- Audit Handling: Handle audits and inspections effectively.
Qualifications & Skills
- Experience: Over 4-5 years in clinical operations within a CRO, Pharma, or Biotech environment, particularly handling large multi-site clinical trials.
- GCP Knowledge: In-depth knowledge of Good Clinical Practice (GCP) guidelines, ICMR guidelines 2017, and the Drugs and Cosmetics Act.
- Monitoring Skills: Experience in remote and risk-based monitoring.
- Research Skills: Strong research and analytical skills with proficiency in clinical trial methodologies and research design.
Competencies
- Integrity & Strategic Thinking: Demonstrate integrity in decision-making and strategic thinking.
- Collaboration & Results Orientation: Excellent interpersonal and communication skills, with a strong orientation towards achieving results.
- Matrix Environment: Ability to work effectively in a matrix environment.
Working Conditions
- Travel: The role is primarily office-based in Mumbai but requires an average of 8 to 10 days of travel outside the office each month.
Why Join Sun Pharma?
Sun Pharma is dedicated to making a difference in healthcare by fostering a culture of innovation, collaboration, and excellence. As a Clinical Research Associate, you’ll be at the forefront of groundbreaking clinical trials that shape the future of medicine.
