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    Start-up Specialist - Mumbai, India - Fortrea

    Fortrea
    Fortrea Mumbai, India

    6 days ago

    Default job background
    Full time
    Description

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

    Summary of Responsibilities:

    • Provide training, utilization, development, and performance review of assigned staff.

    • Lead development of start-up processes.

    • Serve as lead for site related start-up activities, as applicable, during study start-up phase.

    • May present at external and/or internal meetings including, but not limited to BID Defense, Client Kick Off Meetings.

    • Understand client expectations and project specifications to forecast timelines of study startup (up to certain point). Communication of timelines with project managers for projects conducted in the US and UK.

    • Coordinate with GCD start-up, when contracted in support of CPS studies where required (i.e., understand project requirements, secure resources, monitor progress of GCD project team members).

    • Ensure that all start-up staff allocated to assigned project(s) adhere to professional standards and SOPs.

    Participate in identifying SOPs for training matrix for start-up staff. Schedule/conduct training as applicable.

    • Interpret billing guidelines for functional area and train start up team accordingly.

    • Ensure direct reports are trained in the study budgeting process and assist PM in communicating with sites as appropriate. Assist PM and PC with Investigator Grants Estimate (IGE) to ensure estimate reflects the scope of the project.

    • Review and provide input to relative functions areas, for the development of core study documents; oversee Investigator Package compilation.

    • Adheres to parameters to Start-up plans.

    • Oversee IRB/EC/HRA/CA submissions (including amendments as applicable) and approval status (except for Fortrea US CRU studies). Coordinate addressing queries ensuring required timelines are met.

    • Oversee/negotiate NIHR/NHS costing tool templates as applicable. Coordinate queries/updates ensuring required timelines are met.

    • Coordinate PIC site activities as required.

    • Support inspections, internal and client audits. Support resolution of inspection/audit findings for start-up functions.

    • Collate and distribute essential study related documents to regional start-up staff inclusive of all Investigator Package Plan documents, patient facing materials, and any additional documents as required for a project.

    Qualifications (Minimum Required):

    • University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution.

    Experience (Minimum Required):

    • 5 years' relevant clinical research experience including demonstrated skills and competency in clinical project management tasks, especially regarding study start-up.

    • Experience in managing projects in a virtual environment.

    Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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