Clinical Study Project Manager - Mendon - Allen Spolden

    Allen Spolden
    Allen Spolden Mendon

    6 hours ago

    Description

    Job Description

    ESSENTIAL DUTIES

    • Lead and oversee clinical study operations with effective strategic and tactical planning. Ensure smooth organization and direction of study projects, focusing on timelines, reporting, budgeting, monitoring, and managing sites and vendors.
    • Foster clear and positive communication among Sponsors, study teams, and various functional groups to promote a collaborative environment.
    • Motivate and mentor the study team, facilitating their professional growth by identifying skills and creating opportunities for development.
    • Maintain financial oversight of study budgets, ensuring accurate tracking of out-of-scope activities.
    • Collaborate with senior management to provide comprehensive study updates, address resourcing needs, and discuss any sponsor-related issues at regular Project Reviews.
    • Drive the creation and maintenance of detailed project plans tailored to project-specific requirements over the study's duration, including monitoring and communication plans.
    • Ensure compliance with GCP, relevant SOPs, regulatory requirements, and project-specific guidelines throughout all study phases.
    • Properly assess resourcing needs to guarantee the availability of the right resources for each project.
    • Manage and track study risks effectively with input from the team and sponsor, addressing any potential obstacles that could delay progress.
    • Evaluate the training requirements of team members regarding therapeutic areas, protocols, and special procedures, implementing suitable training plans.
    • Delegate responsibilities within the study team, ensuring each member has the necessary tools and resources to excel in their roles.
    • Continuously monitor and manage project progress, developing timelines in collaboration with relevant stakeholders and obtaining sponsor approval, while reassessing the critical path as needed.
    • Oversee activities and deliverables from external vendors, facilitating communication among them, the study team, and the sponsor.

    OTHER QUALIFICATIONS

    • Exceptional interpersonal, oral, and written communication skills.
    • Demonstrated success as a team leader.
    • Extensive experience managing complex studies from inception to completion.
    • Outstanding organizational and time management abilities.
    • Experience managing projects in a virtual setting.
    • Proven capacity to lead by example, encouraging team members to autonomously seek solutions.

    Requirements

    Registered Nurse or Bachelor's degree (or higher) in biological sciences or a related field, or an equivalent combination of relevant experience, education, and previous CRA experience.

    Benefits

    • Attractive salary.
    • Opportunities for career advancement.
    • Comprehensive medical, dental, and vision benefits.
    • 401(k) plan.
    • Commuter benefits.
    • Legal benefits.
    • A great team and supportive workplace culture.

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