Advanced Clinical

  • Advanced Clinical - Project Manager

    Job Locations US
    Req No.
    2018-8888
    Category
    Biotech/R&D/Science
    Type
    Regular Full-Time
  • Overview

    A Project Manager (PM) is responsible for overseeing and conducting clinical research studies and projects. The Project Manager will oversee all assigned clinical research staff to ensure that efficient and effective management of clinical study activities is being maintained. The PM may be responsible for multiple projects and must be able to work independently and in a team environment to effectively lead and drive the project deliverables. The Project Manager will serve as a primary resource and point of communication for the client and project team.

    Responsibilities

    • Support Proposals & Business Development as necessary to secure new business, including but not limited to, providing review and input to Requests for Proposals (RFPs) and presenting at bid defense meetings as requested. 
    • Overall coordination and management of clinical trials from startup to closeout, within the contractual timelines.
    • Project specific financial management, including but not limited to, contract adherence, budget management and regular budget reviews with the client.
    • Provide and/or endure study-specific training for the clinical research staff.
    • Generate a comprehensive and detailed study-specific Project Plan (PP) and ensure underlying functional plans are included.
    • Establish and manage processes to track and analyze critical project information & metrics, including but not limited to, timeline management, project projections and forecasts, and trend and gap analyses.
    • Serve as the primary liaison between the AC study or clinical team and the client.
    • Escalate significant issues to the Director, Project Management or other appropriate AC Operational Leadership.
    • Follow applicable Standard Operation Procedures (SOPs).
    • Ensure compliance with applicable GCPs through training, processes, and early issue identification and correction.
    • Collaborates with other functional areas to identify and evaluate fundamental issues on the project, interpret data, make good business decisions, and ensure the implementation of timely solutions.
    • Develops and implements risk management strategies and contingency plans for clinical deliverables.
    • Maintains a flexible approach to address issues innovatively and proactively.
    • Leads client and cross functional meetings.
    • Oversees study team member performance and assesses workload and resourcing
    • Perform other duties as requested by Director, Project Management

    Qualifications

    The ideal candidate should have Bachelor’s Degree or RN with 5 years industry experience or a Master’s degree with 3 years industry experience or an equivalent combination of education, training and experience. The ideal candidate has excellent organizational and time management skills and can successfully direct projects and deliverables. Must have proven leadership, written and verbal communication skills, and computer competency with Microsoft Word, Excel and Powerpoint. Advanced knowledge of and ability to apply and all applicable regulations and guidelines including GCP. Project management certification is a plus.

     

    Minimum Training Requirements

     

    The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:

    • Applicable Standard Operating Procedures
    • 21 CFR Part 11 and all applicable parts
    • FDA Guidance Documents including ICH E6
    • Drug and Device Development and Approval Process

     

    It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

     

    This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job.  If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

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