Team Member - Clinical Research
Date: February 17, 2025
Location: Sun House - Corporate Office
Company: Sun Pharma Laboratories Ltd
Roles and Responsibilities
Managing CRO-Led Studies
- Oversee Contract Research Organizations (CROs) to ensure smooth execution of interventional, non-interventional, and epidemiological studies.
- Identify and collaborate with CROs and the India Medical Affairs team to select suitable investigators and study sites.
- Assist in the preparation and review of clinical trial documents for submission to Ethics Committees (EC), the Drugs Controller General of India (DCGI), and other regulatory authorities as required.
- Manage vendor relationships in alignment with Sun Pharma’s policies and procedures.
- Coordinate with investigators and study sites for clinical study agreements and financial contracts in collaboration with CROs.
- Work with internal teams, including Medical, Regulatory, and Quality Assurance, to ensure timely regulatory submissions.
- Plan and manage the requisition, procurement, and distribution of investigational products and trial-related materials.
- Ensure timely reporting of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) to regulatory bodies, as well as to all study sites and investigators.
- Provide training to CROs on Sun Pharma’s Pharmacovigilance (PV) procedures.
Managing In-House Studies
- Conduct feasibility assessments, identify potential investigators, and develop study budgets.
- Finalize site and investigator selection, execute Confidential Disclosure Agreements (CDA), and manage study-related contracts.
- Organize and facilitate Investigator Meetings as needed.
- Prepare and submit study documents for Ethics Committee approval across multiple study centers.
- Collaborate with R&D teams to procure investigational products and ensure a seamless supply chain for clinical trials.
- Supervise and document investigational product dispensing, inventory management, and reconciliation.
- Oversee site selection, initiation, monitoring, and closure activities.
- Train investigators and site personnel on study protocols, procedures, and Good Clinical Practice (GCP) principles.
- Ensure efficient patient recruitment and effective data management throughout the study.
- Conduct regular site visits for monitoring, source data verification, informed consent form review, case report form verification, investigational drug accountability, and adverse event assessment. Identify and address deficiencies through corrective measures and training.
- Ensure timely reporting of SAEs and SUSARs, adhering to regulatory requirements and Sun Pharma’s PV policies.
- Organize project meetings and prepare monitoring visit reports.
- Identify risks, conduct analyses, and implement Corrective and Preventive Actions (CAPA) for underperforming study sites.
- Collaborate with in-house teams or CRO partners for data management, statistical analysis, and the development of statistical reports.
- Lead and support data query resolutions in coordination with study sites and the data management team.
- Oversee trial budgets and maintain financial records.
Qualifications and Skills
- 4–5 years of experience in clinical trial operations within a CRO, pharmaceutical, or biotech organization.
- Hands-on experience managing large clinical trials across multiple sites in various therapeutic areas.
- Strong knowledge and experience in remote and risk-based monitoring are advantageous.
- Experience handling audits and regulatory inspections.
- Training in clinical trial methodologies, research design, and ICH-GCP guidelines.
- Comprehensive understanding of New Drugs and Clinical Trial Rules (2019), GCP guidelines, ICMR guidelines (2017), and the Drugs and Cosmetic Act regulations governing clinical trials.
- Solid academic background with expertise in research methodologies.
- Experience working in a matrix business environment is preferred.
- Proven track record of success, demonstrated through performance ratings, professional achievements, or industry recognition.
Job Location
Sun House, Mumbai (Hybrid work options available).
Apply here: from this link
This role is ideal for professionals looking to contribute to cutting-edge clinical research and drive impactful advancements in the pharmaceutical industry.