• Sr. Manager, Global R & D- Investigator Initiated Studies

    Posting Date 1 month ago(11/13/2018 8:52 AM)
    Requisition ID
    2018-5593
    Job Location(s)
    Bloomington IN United States
    Travel
    Less than 10%
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Medical Holdings
    Category
    Engineering
  • Overview

    The primary purpose of this position is to lead the Investigator Initiate Study (IIS) Program for Cook Medical. Manages day to day activities, provides leadership and direction, and prioritizes team efforts in support of program goals and objectives.

    Responsibilities

    • Ensure that adequate resources are available to support initiatives and are coordinated within the organization.
    • Identify unmet patient, market, technology and business needs
    • Develop and manage the process for IIS including evaluations, approvals, contract generation and execution.
    • Communicate status updates externally to investigators & study person- nel & internally to stakeholders and the Executive Research Committee.
    • Maintain accurate budgets for each approved IIS and manage overall program investments.
    • Assure milestone payments are timely and accurate
    • Communicate and provide recommendations to resolve deviations from contract or budget timelines to the Executive Research Committee.
    • Manage product shipments in support of IIS (including, but not limited to, forecasting, ordering, inventory management, & labeling requirements.)
    • Maintain all documentation for each approved and declined IIS.

    • Keep apprised of current regulations and guidance affecting IIS and ensuring the management team is informed of change.
    • Implement policies, programs and directives of senior management.
    • Interview, select, manage performance, and mentor team members
    • Make recommendations for staff and equipment.
    • Foster and maintain a workplace culture respectful and supportive of individual differences in an orderly, sanitary, & safe working environment.
    • Must work and interact effectively and professionally with and for others throughout various levels of the global organization
    • Must maintain company quality and performance standards, including regular, punctual attendance and strict adherence to safety requirements
    • Must have effective oral and written communication skills
    • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.
    • Ability to remain calm and receptive in fast paced situations

    Qualifications

    • Minimum 4 year degree required in Engineering, Science, or Business
    • Advanced degree(s) (e.g., MBA, MS, and/or PhD) is preferred
    • Minimum 5 years of experience in the medical device field
    • Minimum 5 years research and development, product/project management and/or clinical trial experience

    • Sound administrative skills and well-developed management skills
    • Knowledge and understanding of human anatomy, medicine and/or medical devices

     

    Physical Requirements/Work Environment:

    • Must be able to perform the essential functions of the job, with or without
    reasonable accommodations
    • Majority of work is performed in a normal office environment

    • Ability to travel regionally to interact with R&D teams, researchers, business partners and healthcare providers

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