Lead - Clinical Research, (RWE) Medical Affairs

Reporting to General Manager– Medical Affairs, India

Team: 4 direct reports

Education: MD Pharmacology

Department: Medical Affairs

Location: Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” 

Role and Responsibilities

Common Process Management

• Create, adapt and update SOPs & Work instructions for in-house initiated and CRO driven non-regulatory interventional clinical studies, observational studies, cooperative group studies, registries, PRO, EMR studies & IIS
• Ensure adherence to GCP, trial protocols, applicable regulations and administrative requirements for all studies driven by India Medical Affairs
• Develop trackers and monitoring system to track execution of all studies in alignment with plan
• Evaluate IIS concepts received from externals stakeholders in alignment with the IIS SOP and facilitate review with the core group in alignment with the IIS SOP
• Work closely with TA Medical Lead/Advisor for study related activities
• Act as the point of contact for all external and internal agencies
• Prepare and manage budgets in collaboration with all internal and externals stakeholders for all non-regulatory studies conducted by India Medical Affairs
• Reviewing clinical trial protocols, CRF, patient diary (if applicable), ICD, IB, SAR, CSR, study-specific logs, SAE narratives, and ICSRs
• Defend the protocol in SEC meetings with Medical Affairs team members (If needed)
• Ensure seamless execution of all non-regulatory studies conducted by Medical Affairs as per plan
• Maintain an updated Trial Master File in alignment with guidelines and applicable SOPs
• Develop lead daily management matrices to ensure seamless execution of all clinical studies
• Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems
• Handle audits & inspections if any and CAPA management
• Develop risk assessment, risk mitigation and course correction plans for all studies conducted by India Medical Affairs
• Ensure study document archival in alignment with GCP principles and regulations
• Develop and maintain a monthly dash-board driven update for all studies driven through India Medical Affairs

CRO Managed Studies

• Identify and effectively manage CROs for effective execution of for non-interventional, non-regulatory and epidemiological studies
• Identify potential investigators and sites for non-interventional, non-regulatory studies in collaboration with CROs and India Medical Affairs team
• Preparing & reviewing clinical trial documents with Clinical Research Associate (CRA)/CRO for Ethics committee & 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, QA etc.) for timely regulatory submissions
• Plan Investigational Product and other related trial material requisition, procurement, and dispatch.
• Ensure timely reporting of SAEs, SUSARs to regulatory authorities and reporting of SAEs to all sites and investigators.
• Ensure training of CROs on Sun’s PV practices
• Conduct periodic assessment of CROs on a bi-annual basis to evaluate their SOPs, systems and processes

In-House Managed Studies

• Site feasibility, potential investigator identification and development of study budgets for each study
• Finalization of investigators, sites and execution of 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 IP procurement and ensuring streamlined auditable trial supplies to respective sites
• Overseeing & documenting IP dispensing, inventory management & reconciliation
• 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; identifies deficiencies and discrepancies, and provides remedial training and/or initiates 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 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 accounts

People Development and Management

• Effectively identify recruit and develop high quality talent in clinical research operations 
• Responsible for effectively implementing and driving team performance metrics
• Co-ordinate and strengthen team interaction and collaboration within MA team and across cross functional teams within the organization
• Ensure effective stakeholder management through effective collaboration with internal and external stakeholders
• Talent management and development through effective development of IDPs and developmental plans in alignment with IDPs

Related Experience Required

•  > 7 years’ experience in medical affairs
• Experience in real world evidence studies
• Training in clinical trial methodologies, research design and ICH – GCP
• Thorough knowledge of 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
• Experience in people management is desired
• Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards

Competencies

• Integrity driven decision making skills
• Sound functional knowledge in clinical research and operations
• Collaboration and teaming with ability to work in a matrix environment
• Strategic thinking & sound analytical skills
• Big picture orientation with attention to detail
• Sense of urgency & desire to excel
• Intellectual curiosity
• Self-awareness and adaptability to work in a matrix environment
• Result oriented and performance driven
• Excellent interpersonal & communication skills to effectively interact with a broad range of audience

**The role is majority office based but will involve an average 4-5 days of travel outside Mumbai.