Clinical Operations Director
2 days ago
Clinical Operations Leadership Opportunity
Sun Pharmaceutical Industries, Inc.
Job Summary
The Associate Director, Clinical Operations is a key leadership role responsible for overseeing the operational aspects of clinical trials. This includes managing project teams, clinical research associates, and clinical trial associates, as well as motivating, mentoring, and training. The ideal candidate will have a strong background in clinical operations and excellent leadership skills.
Key Responsibilities
- 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 teams for planning, conduct, and reporting of assigned trials.
- Participate in vendor selection process with assigned PMO representative, including proposal development, bid-defense process, and contract review.
- Oversee study start-up activities of CROs, including site identification, feasibility, site selection, contract negotiation, and clinical study agreement finalization.
- Oversee, manage, and assess vendor performance, including timelines and deliverables.
- Develop team and process for carrying out start-up activities for some sites in the US for faster FPI in a global or US-only study.
- Prepare and review budgets for studies managed in-house and review professional fees 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, and assess progress as per pre-set timelines.
- Coordinate finalization of IP label and requisition, forecasting IP requirement during the study, and prepare IP requisition.
- Prepare and review study plans for in-house/outsourced studies, train study team on trial documents, processes, and 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) and study folder and timely tracking of study information.
- Review of study-specific documents, including status reports, site visit reports, and study plans, 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 and finalization of key study documents, including protocol, investigator brochure, informed consent document, case report form, etc.
- Ensure in-house trial closure after completion of all planned activities and oversee archival of all study documents.
- Complete assigned trainings and establish, maintain updated personal training file.
Secondary Responsibilities
- Perform/assist during audit/assessment.
- Participate in meetings and discussions with CROs and support teams.
- Contribute to interview process.
- Contribute to departmental activities, including training, initiatives, and any other activities as assigned by FH.
- Participate in proposal development and in the bid-defense process under guidance and supervision.
Education and Qualification
Bachelor degree in life sciences.
Experience
7-10 years of clinical trial experience.
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