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    Associate Director, Clinical Operations

    Sun Pharma
    7-10 years
    Not Disclosed
    Princeton Junction
    15 July 1, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Associate Director, Clinical Operations

    Company: Sun Pharma Advanced Research Company Limited
    Location: Princeton, New Jersey

    Summary

    The Associate Director, Clinical Operations is responsible for overseeing the Project Management team, Clinical Research Associates, and Clinical Trial Associates. This hybrid role involves motivating, mentoring, and training staff, and is based in Princeton, New Jersey.

    Responsibilities

    Operational Management

    • Oversight of Clinical Trials: Manage all operational aspects of phase I-IV US-based or global clinical trials.
    • Primary Point of Contact: Serve as the main contact for internal and external teams for planning, conducting, and reporting assigned trials.
    • Vendor Selection: Participate in the vendor selection process, including proposal development, bid-defense process, and contract review.
    • Study Start-Up Activities: Oversee CROs' activities such as site identification, feasibility, site selection, contract negotiation, and regulatory submissions.
    • Vendor Performance: Manage and assess vendor performance, ensuring timelines and deliverables are met.
    • Budget Management: Prepare and review budgets for in-house managed studies and review costs for CROs, SMOs, investigators, and vendors.
    • Annual Budget Preparation: Support the Functional Head in preparing the annual studies and department budget.

    Project Management

    • Study Tracking: Manage and track study budget, project milestones, and timelines throughout the study's life cycle.
    • Activity Planning: Plan study activities and timelines, set up tracking tools, and assess progress.
    • IP Management: Coordinate finalization of IP labels and requisitions, forecast IP requirements, and prepare requisitions.
    • Study Plans: Prepare and review study plans for in-house and outsourced studies, and train the study team on trial documents and SOPs.
    • Meetings: Plan and facilitate vendor kick-off and investigator meetings, and meet with investigators and key opinion leaders.
    • Subject Recruitment: Drive subject recruitment for assigned studies, ensuring predefined timelines are met.
    • Quality Control: Implement quality control plans to ensure compliance with ICH-GCP, SOPs, and applicable regulations.
    • Cross-Functional Coordination: Coordinate with cross-functional groups for required deliverables.
    • Trial Documentation: Oversee maintenance and updates of Trial Master File (TMF/eTMF) and study folders, and ensure timely tracking of study information.

    Quality Assurance

    • Document Review: Review study-specific documents including status reports, site visit reports, study plans, protocol deviations, data entry status, and query status to ensure quality.
    • Monitoring: Perform co-monitoring and vendor oversight visits to ensure trial quality.
    • Stakeholder Communication: Provide status updates to stakeholders as required.
    • Process Improvement: Lead process initiatives and improvements as assigned by the function head.
    • Document Development: Contribute to the development and finalization of key study documents, including protocols, Investigator Brochures, informed consent documents, and case report forms.
    • Trial Closure: Ensure in-house trial closure after completing all planned activities and oversee archival of study documents.
    • Training: Complete assigned trainings and maintain an updated personal training file.

    Secondary Responsibilities

    • Audit/Assessment: Assist during audits and assessments.
    • CRO Meetings: Participate in meetings and discussions with CROs and support teams.
    • Interview Process: Contribute to the interview process.
    • Departmental Activities: Participate in departmental activities including training and initiatives.
    • Proposal Development: Participate in proposal development and the bid-defense process under supervision.

    Education and Qualification

    • Bachelor’s Degree: Required in life sciences.

    Experience

    • Clinical Trial Experience: 7-10 years of experience in clinical trials.

    For more information about Sun Pharma Advanced Research Company Limited and to apply for this role, visit www.sunpharma.com.

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