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    Clinical Trial Project Manager - Burlington, United States - Fractyl Health, Inc

    Fractyl Health, Inc
    Fractyl Health, Inc Burlington, United States

    3 weeks ago

    Default job background
    Description

    Reports to:
    Head of Clinical Operations
    Position Summary

    We are looking for a

    detail-oriented


    clinical professional to join our growing Clinical team as a Clinical Trial Project Manager to work closely with Clinical Operations and Medical Affairs to ensure compliance with regulatory authorities.

    The Clinical Trial Project Manager will be responsible for managing multiple projects simultaneously to support the completion of tasks and deliverables.

    Additionally, the position is responsible to communicate cross-functionally, and with Sponsors, vendors, suppliers, contractors, sites, and upper management on project related activities.

    Our ideal candidate is someone who thrives in a fast-paced and dynamic environment, and takes initiative to seek out information, knowledge, and development, proactively.

    They should be a resourceful problem solver who is savvy with technology and finds effective and efficient solutions to complex client problems.

    The Project Manager is a true self-starter who deals well with uncertainty and ambiguity. Lastly, they are a proven team player who puts the success of the team first.

    This role will provide you the opportunity to coordinate and support key product development activities while gaining knowledge of product development.

    Primary Responsibilities
    Details daily coordination, understanding and oversight of scheduled activities, considering responsibilities needed to carry out contracted work and compiling status updates on all project deliverables
    Prepares professional communications and assist in the design of new tasks and projects
    Coordinates and/or conducts investigations to resolve data discrepancies and reconcile data as appropriate
    Assist clients, collaborators, and senior management in the implementation of new projects and expanded work scopes
    Understands project scope including the creation of or supporting the Project Manager in compiling and maintaining project timelines, and attending internal and client meetings
    Preparation and submission of all required documents to internal and external stakeholders
    Proactively anticipates and facilitates future business opportunities with existing and prospective clients
    Independently conducts regularly scheduled touch bases with clients
    Maintains contract/project financial data
    Stay apprised of all repository and laboratory operations (fresh/frozen sample handling, data entry, shipping, etc.) if needed
    Reviews and approves all documentation associated with project(s) as required
    Following up on action items to ensure completion
    Project resource planning and reporting of project forecasts and actuals
    Track detailed technical deliverables and provide outlook on future deliverables
    Communicate with key business partners (internal and external) to ensure accurate and up to date information is maintained for program delivery
    Provide regular (weekly/biweekly) project communications with Clin Ops regarding key clinically meaningful data

    Perform all activities in compliance with applicable regulations, Fractyl's policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.

    Bring a "can do" spirit to work and deliver on other responsibilities as assigned.
    Education or Certification Requirements

    Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field 1-4 years of clinical research experience in industry settings as a CPM.

    At least 3 years of project management experience is strongly preferred
    Professional Work Experience

    Previous industry experience as a CPM that provides the knowledge, skills, and abilities to perform the job (comparable to 3 years) or equivalent combination of education, training, & experience.

    Demonstrate working knowledge of internal SOP's, FDA/lCH guidelines to GCP's and regulatory compliance.
    Global experience in North America and EU is a prerequisite
    Experience with line management for a team required to deliver time-sensitive objectives.
    Experience managing remote employees preferred.
    Experience with outsourcing.
    Experience with budget development, negotiation, forecasting, and finance processes.
    Experience implementing large-scale change and process improvements relating to medical operations and/or clinical trials.
    Applicable experience in biotech, pharmaceutical and/or medical device industries preferred.
    Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
    Qualifications and Skills
    Must have knowledge of and direct experience with

    Microsoft Office:
    Word, Excel, PowerPoint, OneNote, Outlook, and Adobe Acrobat.
    Experience with controlled clinical terminology and clinical trial systems such as TMF/eTMF, CTMS, EDC, IVRS/IWRS, ePRO is highly preferred
    Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partners
    Ability to effectively conduct oral presentations
    Demonstrated experience in identification and resolution of technical problems in a professional environment
    Ability to attain, maintain and apply a working knowledge of applicable procedural documents
    Prior regulatory experience is a plus
    Ability to maintain a high degree of confidentiality with clinical teams
    Other Essentials and Key Success Factors
    Successful track record of working in high-growth and dynamic organizations
    Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
    Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
    Evidence of "hands-on" experience and expertise
    Proven and successful track record as a team-player and collaborator in small working environments
    Highly organized and detail oriented with a passion to deliver quality results
    Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
    Highest levels of professionalism, confidence, personal values and ethical standards
    Travel

    This position requires no regular travel but ability to travel as needed required

    The description and requirements outlined above are general; additional requirements may apply.
    #J-18808-Ljbffr
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