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Director, Clinical Operations

2 months ago

Princeton, United States Sun Pharmaceutical Industries, Inc. Full time
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