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Program Manager

Company: Labcorp
Location: Morrisville
Posted on: May 15, 2022

Job Description:

We are seeking a Program Manager to support our Companion Diagnostics Group.
The Program Manager is responsible for managing complex Product Development projects from feasibility to commercial launch for In Vitro Companion Diagnostic (IVD) Assays. - Projects will be performed in accordance to Design Control procedures and Stage Gate approval process, as outlined in standard operating procedures. -
The Program Manager will act as the primary point of contact for each program and will guide the joint project team (JPT) to deliver on program objectives by coordinating activities between functional groups. - Throughout the program, this individual will maintain open and frequent communication with the Sponsor and internal functional teams and will ensure completion of deliverables in compliance with established standard operating procedures.
The Program Manager must demonstrate strong leadership across the JPT, keeping a collaborative attitude and fostering continuous and effective communication within the team. The Program Manager must also be able to combine a strong understanding of protocol specifics and study feasibility, to ensure successful project management and outstanding customer service.
General Responsibilities:

  • Manage a portfolio of global, high-complexity studies and serve as the primary point of contact providing program oversight for the duration of the product development life cycle.
  • Maintains ownership of the program to include relationship with Sponsor, timelines and delivery to contracted milestones.
  • Will act as the liaison between Product Development and the Diagnostic Development Services, clinical support and scientific teams at the regional/specialty testing locations as appropriate. -
  • Consult with Business Development and Commercialization teams for contracting and deployment strategies.
  • Responsible for providing regular status updates to include compliance and timeline risks and communication of any suggested actions to all parties involved.
  • Liaise with internal cross functional project team, to include the external Pharma partner (if applicable) to manage timelines and product development activities.
  • Establish and manage Joint Project Team (JPT) meetings to include the Organization of agendas, as well as the collection and distribution of meeting minutes and action items.
  • Track project status, issues, timelines and action items.
  • Identify and communicate proactively, project risk and contingency plans.
  • Facilitate design reviews and stage exits to include distribution of decisions and action items.
  • Ensures program compliance to quality and regulatory standards as outlined in standard operating procedures.
  • Prepare, organize and host CRA visits as needed. Prepare, coordinate set up and monitors study timelines with the laboratory, the CRA and all CLS departments involved.
  • Assist during Sponsor/Regulatory inspections and actively participate in meetings as needed.
  • Prepare training support material for Laboratory staff to enhance and sustain study compliance.
  • Prepare regulatory authority applications.
  • Ensures that all customer expectations are documented and executed in compliance with regulatory and quality system requirements.
  • Proper escalation of program risks and/or inconsistencies and communication of any proposed corrective and preventive actions.
  • Proactive assessment and reporting on program status.
  • Effective management of the Program budget.
  • Real-time maintenance and archival of all product related documentation.
    Additional Responsibilities:
    • Facilitate and participate in project and team meetings to include the generation and distribution of agendas and meeting minutes.
    • Organize and archive product documentation and program related correspondence to include maintenance of the DHFI/DMRI.
    • Filing and collating Final Design / Device documentation and reports.
    • Evaluate compliance of associated clinical programs which may include performing physical inventory of study materials as needed. Reporting protocol deviations and Adverse Events as needed to the global diagnostic Study Manager, Principal Investigator/Scientist, Regulatory Affairs and Quality Assurance as appropriate.
    • Track monthly billable service activities.
    • Participate in development through continuous process improvement, quality and productivity.
    • Demonstrate ability to effectively manage multiple complex and dynamic programs with tight timelines and high administrative demand.
    • Other duties as needed
      Labcorp is proud to be an Equal Opportunity Employer:
      As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
      For more information about how we collect and store your personal data, please see our - -

Keywords: Labcorp, Cary , Program Manager, Executive , Morrisville, North Carolina

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