Title:  Team Member - Clinical Research

YOUR TASKS AND RESPONSIBILITIES:

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
• Coordinate with internal stakeholders (Medical, Regulatory, Quality Assurance etc.) for timely regulatory submissions
• Plan Investigational Product and other related trial material requisition, procurement, and dispatch
• Ensure timely reporting of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSAR) to regulatory authorities and reporting of SAEs to all sites and investigators
• Ensure training of CROs on Sun’s Pharmacovigilance (PV) practices

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

WHO YOU ARE:

• 4–5 years’ experience in a CRO/Pharma/Biotech organization in clinical trial operations
• Experience in handling large clinical trials with multiple sites for different therapeutic areas
• Thorough Knowledge & experience of remote and risk-based monitoring will be of added value
• Must have experience in handling audits & inspections
• Training in clinical trial methodologies, research design and ICH – GCP
• Thorough knowledge of New Drugs and Clinical Trial Rules, 2019, GCP guidelines, ICMR guidelines 2017 and Drugs and Cosmetic Act regulations pertaining to clinical trials
• Strong academic record with strength in research with knowledge of research methodologies
• Experience of working in matrix business environments preferred
• Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards

Job Location: Sun House, Mumbai (Open for Hybrid working)