Program Manager - Early Development Services

LabConnect   •  

Johnson City, TN

Industry: Pharmaceuticals & Biotech

  •  

Less than 5 years

Posted 105 days ago

This job is no longer available.

Program Manager – Early Development Services - Johnson City, TN/Remote


The Program Manager is responsible for oversight of the provision of project management services for the company’s Early Development Services (EDS) projects on a worldwide basis for a client portfolio/program.

The Program Manager creates program plans specific to client needs and oversees the day-to-day activities of these programs and deliverables, including a program's efficiency, service delivery, and staff performance through KPI management. This individual manages client requests, escalates issues when appropriate and works to ensure that program staff is knowledgeable and effective with services executed as outlined in the study SOW and client program plan. The Program Manager provides leadership, management, and mentorship to the study teams and is responsible for the execution of program plans of multiple clinical trial projects with the client/sponsor. In addition, s/he will perform duties associated with day-to-day oversight of ongoing clinical trial study projects to ensure quality deliverables are on time and within budget.

Responsibilities:

  • Creates and implements Program Plans with applicable clients.
  • Tracks and monitors necessary KPI’s as outlined in the program plan
  • Ensures appropriate communication pathways for issue escalation and resolution are followed between the client and LabConnect.
  • Ensures communication plans are created and adhered to amongst all parties and vendors.
  • Provides ongoing oversight for clinical trial projects assigned, including client meetings and communications, report development and review, issue resolutions, and budget oversight.
  • Conduct regularly scheduled governance meetings with client to review overall program outlined in the program plan and review of KPI’s.
  • Participates in the handover process between Business Development (BD) and the EDS Project Manager, and in the training process of internal staff.
  • Oversees the activities of the LabConnect EDS Project Management team assigned to the individual studies.
  • Primary program contact with the Sponsor and their designated Contract Research Organizations on a worldwide basis to ensure appropriate communication channels are maintained and reporting schedules adhered to.
  • Translates client requirements into actions for problem solving, issue resolution, or to provide requested information; often requires a creative approach to serving client needs while adhering to internal process and standards. This includes collaboration between all stakeholders (internal and external) to create and carry out said solution.
  • Works closely and in coordination with clinical laboratory management and directors in support of clinical trials.
  • Interfaces with global laboratory partners, Business Development, Clinical Trial Materials, and Data Management.
  • Liaises with other project managers to ensure study-related tasks have been performed, and with the assigned data manager to ensure data is delivered on time per the SOW.
  • Monitors and analyzes the operational, quality, and performance of project manager deliverables, address quality issues, identify opportunities to improve training, and execution and data flow across all trials within the assigned program. Provides timely reports to the client and LabConnect management.
  • Liaises with managers/supervisors in other departments to stay informed of operational changes or issues.
  • Collaborates with project managers in partner laboratories to provide a global overview of study management.
  • Ensures that all laboratory requirements outlined in the protocol are managed per expectations and in compliance with laboratory practices.
  • Represents LabConnect at client and/or investigator meetings, including periodic client visits.
  • Performs other related duties and tasks as necessary or as assigned.

Education/Experience:

  • Bachelor's degree (B.A./B.S.) from four-year college or university; and three to four years central laboratory experience or related clinical experience.
  • Must be experienced in customer service and possess excellent organization and interpersonal, communication and problem solving skills.
  • Must be adept at stress management.
  • Microsoft Office applications including word processing, spreadsheets, PowerPoint, and MS project.
  • Certification as an ASCP Medical Technologist and/or Registered Nurse is preferred.
  • Supervises employees in the Project Management Department.

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