Director, Clinical Operations

Director, Clinical Operations/CPM

Sun Pharma Advanced Research Company, Limited                                        

Summary

• The Director, Clinical Operations/CPM is responsible for the development of a Clinical Operations Team in the United States. Work with Function Head in Resource planning and assignments across studies.

Responsibilities Assigned:

• Team Mentoring, Motivating, Training and Oversight for a team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs).
• Oversee and manage all operational aspects of phase I-IV US based or global clinical trials
• Act as primary point of contact for internal and external team for planning, conduct, and reporting of assigned trials.
• Participate in vendor selection process with assigned PMO representative. This includes proposal development, bid-defense process, and contract review.
• Act as primary point of contact from clinical operations for assigned trials.
• Oversee study start up activities of CROs (e.g. Site identification, Feasibility, Site selection, Contract negotiation and Clinical Study Agreement finalization, Translations, EC and Regulatory submission, Site initiation etc.).
• Oversee, manage and assess vendor performance (timelines and deliverables).
• Develop team and process for carrying out start up (site identification, feasibility, selection, EC submission, contracting and SIV readiness) for some sites in US for a faster FPI in a Global or US only study.
• Budgets- prepare/review budgets for studies managed in house and review professional fee and pass through costs for CROs, SMOs, Investigators, and vendors, as applicable.
• Support Functional Head in preparation of annual studies budget and department budget.
• Manage and track study budget, project milestones, and timelines throughout the life of the study and perform contract reconciliation at study end.
• Plan study activities and timelines and share with stakeholders, set up tracking tools for assigned trials & assess progress as per pre-set timelines.
• Co-ordinate finalization of IP label & requisition. Forecasting of IP requirement during the study and prepare IP requisition.
• Prepare/Review study plans for in-house/outsourced studies. Train study team on trial documents, processes & assigned SOPs.
• Plan and Facilitate vendor kick-off meetings and Investigator Meetings for study.
• Meet investigators and key opinion leaders for assigned trials.
• Drive subject recruitment for assigned studies and meet predefined timelines.
• Prepare and implement Quality control plan in assigned studies and ensure that clinical studies (in-house or outsourced) are in compliance with ICH-GCP, SOPs, and applicable regulations.
• Coordinate with cross functional groups for required deliverables.
• Oversee maintenance and timely update of Trial Master File (TMF/eTMF) & Study folder and timely tracking of study information.
• Review of study specific documents including status reports, site visit reports & study plans and other reports i.e. Protocol Deviations, Data entry & SDV status, Query status etc. and ensure quality in the study.
• Perform Co-monitoring and vendor oversight visits to ensure quality of trial conduct.
• Provide status update to stakeholders as per project requirement.
• Lead process initiatives and improvements as assigned by the function head 
• Contribute to development & finalization of key study documents (i.e. protocol, Investigator brochure, informed consent document, case reports form etc.)
• Ensure in-house trial closure after completion of all planned activities and oversee archival of all study documents.
• Complete assigned trainings & establish, maintain updated personal training file.
• Line Management, team management and performance appraisal for assigned resources.

Secondary Responsibilities:

• Perform/Assist during Audit/Assessment.
• Participate in meetings and discussions with CROs and support teams.
• Manage managers & resources performing lead activities.
• Contribute to interview process.
• Contribute to Clinical Development Strategy.
• Contribute to departmental activities including training, initiatives & any other activities as assigned by FH.
• Participate in conferences & workshops.
• Participate in proposal development and in the bid-defense process under guidance and supervision.

Education and Qualification

Bachelor of Science in a life sciences discipline, or higher qualification

Experience

10+ years of Clinical trial experience