Associate Laboratory Project Set Up Manager
IQVIA
Buenos Aires, AR
hace 6 días

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.

Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

PURPOSE

  • Under general supervision, manage the process of designing and launching single region, less-complex global / regional clinical research studies under general direction;
  • lead activities of the Sponsor / Clinical Research Organization (CRO), and guide the Project Manager (PM) and Set-up Coordinators (SC) in designing and organizing project components.

    RESPONSIBILITIES

    Develop the database design requirements which include configuration (project specific kit contents, laboratory events, requisitions, medical reports), programming for full protocols and protocol amendments, and developing and maintaining client design standards as applicable.

    Perform database configuration and programming review and approve verification unit testing while adhering to the database design requirements.

    Collaborate with senior colleagues during planning meetings regarding project timelines, and project-related issues focusing on capabilities within Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management.

    Responsible for updates to the project tracking database, action / issues logs, status sheets and timelines during the set up phase.

    Communicate and coordinate set-up activities with clients and internal customers to ensure approvals are met, launch is successful, and a seamless transfer of the project to the Project Manager.

    Lead in the development of sponsor specific standards and program-specific set-up procedures.

    Lead in the identification and resolution of service level issues and where issues affect other projects within and across programs to ensure that any solution is employed universally.

    Ensure lessons learned are considered, shared and improvements included in study design process. Oversee the writing of protocol-

    specific laboratory instruction manuals / participate in the preparation and maintenance of the laboratory specifications document for each protocol within a program as appropriate.

    As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings.

    Provide additional training to sponsor, CRO, and site personnel as required (telephone training, attendance at CRA training meetings, site refresher meetings, etc.).

    Participate in external and internal audits as required.

    Coordinate and mentor more junior staff; may assist in training new staff on assigned to projects.

    Report on team performance against contract, customer expectations, and project baselines to management.

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