Job Description

PURPOSE Project Lead is responsible for ensuring conduct of multi-national clinical trials in compliance to applicable regulatory framework. Accountabilities include but are not limited to study timelines, study budget, data quality and study conduct in accordance with SOPs and ICH/GCP and regulatory guidelines & directives. The PL acts as the key operational interface with internal and external stakeholders to develop, implement, maintain and improve operational processes for clinical trial conduct. Project Lead will also be responsible for direct line-management of Clinical Operations team members and is also responsible to contribute towards functional capability building initiatives. The PL oversees at a project level the Study Manager, Clinical Research specialists and Clinical Research Associates (CRAs) with awareness of related functions and roles. Participate CRO/Vendor Identification, Evaluation and Selection Process \'Identify different CRO/Vendors and roll-out RFI and RFP Assess RFI/RFP information and shortlist CRO for further comparisons, discussions with HOD and senior leaders Participate in vendor selection visits as Clinical Operations SME Facilitate CRO/Vendor finalization\' Planning and execution of clinical trials \'Contribute in developing Clinical trial execution strategies/plan and also execute the clinical trials as per Clinical development strategies. Perform IP/RMP forecast for the entire project and monitor the inventory at depot and at sites to ensure adequate drug is available. Perform reconciliation at the end of study Define various recruitment initiatives in coordination with CRO/vendor Contribute in review and finalization of various clinical trial documents/plans like Study Monitoring Plan, project management/communication plan, RACI etc. Provide Clinops inputs to various study documents viz. protocol, ICF, CRF etc. Review various project specific Work orders, Change Orders, study invoices etc. Ensure compliance of sponsor oversight plan by reviewing monitoring reports, CRF data, monthly listings/reports, perform onsite visits etc. Establish and maintain relationship with clinical trial sites Ensure overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s) Ensure all aspects of study site management i.e. recruitment of qualified investigators, site initiations, conduct investigator meetings, ensure enrolment criteria are met and other aspects of the study management as appropriate. End to end vendor management \'Build and maintain good working relationship with CRO/Vendor Prepare and conduct F2F meetings with CRO on need basis\' Attend various governance meetings Participate in various governance meetings like Internal and External Project Team meetings, Medical calls, Data Management calls, CRA meetings etc and other internal and external governance meetings. People Management Conduct goal setting, performance appraisals and mentoring/coaching for team members. Collaborate with HOD in manpower planning, recruitment activities and identifying training needs of team members. Provide training to team members on new processes when required\' Contribute to various functional capability building initiatives \'Develop and review various SOPs, Work Instructions, study manuals Consolidate lessons learnt and share best practices with cross functional teams\' Trial Master File Review and Maintenance for Inspection Readiness \'Ensure that CRO/ sites are timely updating the TMF/CCF Ensure adequacy of TMF for all time inspection readiness Review and assist the CRAs/CROs in closure of TMF findings Perform TMF reviews during sponsor oversight visits \' REQUIREMENTS Education Qualifications: Master /Bachelor Degree in life sciences or allied medical fields (e.g., B. Pharm./M. Sc. (Life science)/ M. Pharm./M.B.B.S./Ph.D.) Experience : Minimum of 10 years of clinical research experience; 1-2 years of field monitoring experience; and in addition 2 or more years of prior experience as a manager in a pharmaceutical setting.Operations experience of which at least 2 years in Biosimilar studies and 2 years of Project management. Business Understanding : Understanding of biosimilar development, awareness about regulatory guidances for the conduct of clinicals trials in India and other regularatory agencies, knowledge on Biosimilar Competetive Intelligence; Reasonable knowlegde on techno

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