Are you a seasoned professional in clinical research with a passion for driving impactful clinical trials? Sun Pharma Laboratories Ltd, a leading name in the pharmaceutical industry, is seeking a Team Member – Clinical Research to join their dynamic team. If you have 4–5 years of experience in clinical trial operations and a strong understanding of regulatory guidelines, this could be the perfect opportunity for you.
Your Tasks and Responsibilities
CRO Managed Studies
As a Team Member – Clinical Research, you will play a pivotal role in managing Contract Research Organizations (CROs) to ensure the effective execution of interventional, non-interventional, and epidemiological studies. Your responsibilities will include:
- Identifying potential investigators and sites for clinical studies in collaboration with CROs and the India Medical Affairs team.
- Supporting the preparation and review of clinical trial documents for Ethics Committee (EC) and Drugs Controller General of India (DCGI) submissions.
- Managing vendors in compliance with Sun Pharma’s policies and procedures.
- Coordinating with investigators and sites to execute clinical study agreements and financial agreements.
- Collaborating with internal stakeholders (Medical, Regulatory, Quality Assurance, etc.) for timely regulatory submissions.
- Planning and overseeing the requisition, procurement, and dispatch of investigational products and trial materials.
- Ensuring timely reporting of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) to regulatory authorities.
- Training CROs on Sun Pharma’s Pharmacovigilance (PV) practices.
In-House Managed Studies
For studies managed in-house, you will:
- Conduct site feasibility assessments, identify potential investigators, and develop study budgets.
- Finalize investigators and sites, and execute Confidential Disclosure Agreements (CDAs) and study-related contracts.
- Plan and conduct Investigator’s Meetings as needed.
- Prepare and submit study documents for EC permissions across centers.
- Facilitate Investigational Product (IP) procurement and ensure streamlined trial supplies to sites.
- Oversee IP dispensing, inventory management, and reconciliation.
- Conduct site selection, initiation, monitoring, and close-out activities.
- Train investigators and site personnel on study protocols, procedures, and Good Clinical Practice (GCP) principles.
- Ensure timely recruitment of trial participants and efficient data management.
- Conduct regular site monitoring visits, source data verification, and case report form reviews.
- Manage trial budgets and maintain accounts.
Who You Are
To excel in this role, you should have:
- 4–5 years of experience in clinical trial operations within a CRO, Pharma, or Biotech organization.
- Proven experience in handling large clinical trials across multiple sites and therapeutic areas.
- Thorough knowledge of remote and risk-based monitoring.
- Experience in handling audits and inspections.
- Training in clinical trial methodologies, research design, and ICH-GCP guidelines.
- Strong understanding of New Drugs and Clinical Trial Rules, 2019, GCP guidelines, ICMR guidelines 2017, and Drugs and Cosmetic Act regulations.
- A strong academic background with expertise in research methodologies.
- Experience working in matrix business environments is preferred.
- A track record of success demonstrated through performance ratings, professional accomplishments, or awards.
Why Join Sun Pharma?
Sun Pharma Laboratories Ltd is a global leader in the pharmaceutical industry, committed to improving healthcare outcomes through innovative research and development. By joining our team, you will:
- Work in a collaborative and supportive environment.
- Gain exposure to cutting-edge clinical research projects.
- Enjoy the flexibility of hybrid working arrangements.
- Be part of a company that values professional growth and development.
