Clinical Research Sun Pharma – Apply Now!
Are you passionate about clinical research and looking for an opportunity to make a significant impact? Sun Pharma Laboratories Ltd is hiring a Team Member – Clinical Research at its Sun House Corporate Office in Mumbai. This role involves managing CRO-led and in-house clinical trials, ensuring compliance with regulatory standards, and collaborating with medical, regulatory, and quality assurance teams. If you have 4–5 years of experience in clinical trial operations, this could be the perfect role for you!
CRO Managed Studies
- Manage Contract Research Organization (CRO) for effective execution of interventional, non-interventional and epidemiological studies
- Identify potential investigators and sites for clinical studies in collaboration with CROs and India Medical Affairs team
- Support in preparation and review of clinical trial documents for Ethics committee (EC) & Drugs Controller General of India (DCGI) and/or other regulatory submission (as applicable)
- Vendor management as per Sun Pharma’s applicable policies & procedures
- Coordination with investigator and sites for executing clinical study agreements & financial agreements in co-ordination with CRO
In-House Managed Studies
- Site feasibility, potential investigator identification and development of study budgets for each study
- Finalization of investigators, sites and execution of Confidential Disclosure Agreement (CDA) and study related contracts
- Plan and conduct Investigator’s Meeting if needed
- Preparation and submission of study documents for EC permission for respective study across centers
- Work with R&D teams and facilitate Investigational Product (IP) procurement and ensuring streamlined auditable trial supplies to respective sites
- Overseeing & documenting IP dispensing, inventory management & reconciliation
- Site selection, Site initiation, Site monitoring and Site close-out activities
- Investigator and site personnel training on Study protocol, procedures and GCP principles
- Ensure timely recruitment of trial participants and subsequent efficient and effective data management
- Ensure regular site monitoring visits as per plan, source data verification, informed consent form review, case report form review, investigational drug accountability, and adverse event review for completeness, accuracy, consistency, and compliance; identify deficiencies and discrepancies, and provide remedial training and/or initiate corrective action as required
- Ensure timely reporting of SAEs, SUSARs and reporting of SAEs to all sites and investigators in
- alignment with regulations and Sun’s PV policies
- Coordinate project meetings and preparation of monitoring visit reports
- Risk identification, analysis and Corrective and Preventive Action (CAPA) for sites not meeting
- expectations as per plan
- Co-ordinate with in-house or CRO partners for data management, statistical analysis & statistical analysis report
- Lead & guide data query resolutions in coordination with sites and data management team
- Management of the trial budget(s) and maintenance of the account
Qualifications
4–5 years’ experience in a CRO/Pharma/Biotech organization in clinical trial operations.
Keywords: Job Posting, Clinical Research, Sun Pharma, Mumbai, CRO, Clinical Trials, Research Operations, GCP Guidelines, Pharma Careers
