OMNI Human Resource Management

  • Project Manager

    Job ID
    2018-2155
    Client
    Vince & Associates Clinical Research
    Job Location(s)
    US-KS-Overland Park
  • Overview

    Altasciences- Vince and Asso

    Do you want a fast-paced, exciting and innovative career in research? Join a team that is at the forefront of advancing medicines! Vince and Associates Clinical Research is currently looking for a Project Manager for their Overland Park, KS campus.

    Altasciences Clinical Research, encompassing Algorithme Pharma, Vince and Associates Clinical Research and Algorithme Pharma USA, is one of the largest early phase clinical research organizations (CROs) in North America. As a leading, full-service CRO, we have extensive expertise in the execution of a wide range of Phase I/II clinical studies, especially complex trials in healthy normal volunteers and patient populations.

    The Project Manager will be responsible for the management of innovator Phase I/II clinical studies. The Project Manager (PM) leads the operational study team, manages key relationships with internal and external stakeholders and oversees all aspects of a given project to ensure successful execution. The PM develops and proactively manages study timeline and is responsible for the scope of work including third party vendor involvement. The PM adequately evaluates probability and impact of risk, develops and implements risk management plans to mitigate effect on project objectives and deliverables, and effectively navigates project budgets towards expected profitability.

    DP-IND

    Responsibilities

    • Independently execute clinical trials from study award through archival
    • Develop project-specific timelines and proactively manage the critical path to ensure on-time execution and delivery per scope of work
    • Assess out of scope activities for potential change orders
    • Act as the central point of contact for all internal and external stakeholder inquiries during execution of a project and maintain effective and efficient communication with all parties
    • Ensure critical milestones are met using autonomy and interpersonal skills
    • Manage and coordinate, along with the study team, any situation impacting study outcome and escalate as appropriate
    • Plan and execute internal and external study team meetings
    • Coordinate, review and approve study related documents including but not limited to protocols, informed consents, study manuals and plans, case report forms
    • Create and maintain the Trial Master File, and ensure inspection readiness
    • Support submissions to institutional review boards and regulatory agencies
    • Work with Quality Assurance to ensure GCP and regulatory compliance is maintained
    • Facilitate process of identification, selection, initiation, monitoring, and close out of appropriate investigational sites
    • Review critical study data for accuracy and evaluation of protocol endpoints
    • Provide effective oversight of third-party vendors
    • Facilitate Lessons Learned meetings
    • Participate or host client visits as required
    • Provide assistance to Business Development in promoting Altasciences' services.

    Qualifications

    • Bachelor or higher level degree in Pharmacy, Pharmacology, Medicine, Sciences. Equivalent fields and /or equivalent experience could be considered.
    • Minimum 4 years of clinical research experience required including 2 years of Project Management
    • Proficiency using Microsoft Office (including MS Project) and Electronic Case Report Forms
    • Client services approach (internal and external)
    •  Problem solving and risk mitigation

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed