Lupin Pharmaceuticals (Company Headquarters)

  • Clinical Project Manager

    Job Locations US-PA-Bluebell
    Posted Date 4 weeks ago(4 weeks ago)
    Job ID
    2018-2372
    # of Openings
    1
    Category
    Other
  • Overview

    Lupin is among the top five pharmaceutical companies in India and is an innovation led transnational pharmaceutical company developing and delivering a wide rage of branded & generic formulations, biotechnology products and APIs globally.  Lupin is committed to bringing innovative products for the healthcare professionals to improve the health and well-being of individuals.

     

    We are actively recruiting for a Clinical Project Manager to be based in our BlueBell, PA office.

    Responsibilities

    Role and Responsibilities

    • Proactively manage project level operational aspects of a clinical trial including management of trial timeline, budget, resources and vendors.
    • Provide efficient updates on trial progress with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
    • Lead study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
    • Ensure effective project plans are in place and operational for each trial and work proactively with the clinical trial team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
    • Chair working group and vendor status update meetings and ensure applicable meeting minutes are completed, distributed to team members.
    • Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
    • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
    • Review and approve vendor invoices in collaboration with the accounting team to ensure investigator payments occur in a timely manner
    • Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
    • Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
    • Other duties as assigned

    Qualifications

     

    Qualifications and Education Requirements

    • Bachelor’s Degree in related field with 7 years of experience in industry and/or a contract research organization and 5+ years of experience within a clinical operations function.
    • Demonstrates extensive global clinical trials/program management experience
    • Demonstrates excellence in complex project management and effective management of multiple projects/priorities and budgets, ranging from early to late development programs
    • Understands comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical development operations
    • Extensive experience managing Operations resource through a CRO outsource model
    • Demonstrates proven ability to lead multifunctional teams
    • Extensive experience of vendor oversight and managing external partnerships and relations
    • Excellent verbal, written, interpersonal and presentation skills

     

     

     

     

     

     

     

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