Jobs

    Clinical Project Manager - Massachusetts, United States - Pharma People

    Pharma People
    Pharma People Massachusetts, United States

    2 weeks ago

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    Description

    Our client, a well-established Medical Device company in the MA area, is looking for a Clinical Project Manager to oversee an exciting new project. The Clinical Project Manager will be responsible for leading a new study in dermatology and overseeing both scientific and operational aspects.

    Responsibilities:

    • in planning, setup, maintenance, and closure of the new clinical research study.
    • manage all aspects of trial processes, including vendor selection, site feasibility, clinical timelines, budgets, resources, and vendor relationships.
    • day-to-day study management, overseeing CROs, study vendors, and investigational sites in coordination with cross-functional team members.
    • external partners' work to ensure service quality aligns with agreed timelines and budgets.
    • in drafting, reviewing, and updating clinical development documents such as Protocols, Informed Consent Forms, Investigator's Brochures, etc.
    • effective project plans are implemented for each trial within appropriate SOPs.
    • and mitigate risks, applying strong problem-solving skills for timely issue resolution.
    • interdisciplinary project tasks including site monitoring/audits, data collection, safety management, document management, etc.
    • the trial-specific Trial Master File (TMF) and support periodic audits.

    Requirements & Qualifications

    • Bachelor's degree in life sciences or a related field.
    • Minimum of 5 years' experience in Clinical Trial Project Management or Clinical Operations.
    • Strong understanding of clinical trials, preferably with experience in early-phase trials
    • Strong knowledge of Cell and Gene therapy clinical trials.
    • Proficiency in ICH GCP, drug development, clinical research industry practices, and regulatory processes.
    • Ability to work independently and with minimal supervision
    • Ability to foster successful professional relationships with internal teams, vendors, and investigational sites.
    • Proficiency in Microsoft Office products and electronic platforms (CTMS, eTMF).
    • Experience in start-up procedures, conflict resolution, risk management, and project financials management.
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