• Clinical Project Manager / Senior Clinical Project Manager

    Job Locations US-MA-Cambridge
    Job ID
    2018-1095
    # of Openings
    1
    Category
    Clinical Operations
  • Overview

    Reporting directly to the Head of Clinical Operations, this is a high-visibility, high-impact position in a small fast-paced clinical operations team. This role provides a unique opportunity for the right individual to lead one or more early and late phase clinical studies of a first-in-class oncology product candidate and to shape our development operations team as we grow.

    Responsibilities

    • Lead matrix, multi-disciplinary, cross-functional study execution teams from start-up through close of a study to ensure both internal and external deliverables are on time and on budget while ensuring collaboration occurs across functional areas. Coordinates the relevant and timely exchange of information / materials to support clinical trials delivery.
    • Oversees the development of clinical trial project timelines and ensures communication and understanding of risks / challenges; establishes mitigation plans and monitors metrics; ensures that timelines are accurate and comprehensive.
    • Proactively and independently oversee and manages vendors including identification and mitigation of risk to ensure trial deliverables and performance goals are met.
    • Ensures comprehensive approach to clinical trial execution including trial master file, site and monitor oversight as well as development of quality and performance metrics.
    • Day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with the sites and communicates/escalates to Project Manager or senior Clinical Operations staff.
    • Collaborate with Data Management and CRO to keep clinical study database current and accurate.
    • Accountable for meeting agendas and comprehensive and precise meeting minutes.
    • Assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations.

    Qualifications

    • A Bachelor’s degree in a scientific discipline or health related field (e.g., nursing, pharmacy, physician’s assistant) with an advanced degree preferred.
    • Candidates should have a minimum of 5 years of clinical research experience (or equivalent).
    • Demonstrated proficiency in clinical trial planning and start up (including budget planning; experience in resource planning preferred), and in executing a wide range of clinical trial activities preferably from start up through final study report, and vendor management.
    • Experience and expertise in managing early through late-stage oncology studies.
    • Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing clinical trial conduct.
    • Strong verbal, written and presentation skills are required.
    • Experience leading of a matrixed cross-functional team.
    • Ability to work independently and in a team environment.

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