Sr. Clinical Project Management

2 weeks ago

Piscataway, United States Pharmaron Full time
Job DescriptionJob Description

Senior Clinical Project Manager - Pharmaron USA

Pharmaron USA is a leading global contract research organization (CRO) specializing in providing comprehensive drug discovery, development, and manufacturing services.

As we continue to expand, we are seeking a highly skilled and experienced Senior Clinical Project Manager to join our dynamic team. This is a pivotal role responsible for overseeing the direction, implementation, coordination, and execution of global-scale clinical projects.

Key Responsibilities:

  • Collaborate with heads of relevant functional departments to review project contracts and identify necessary project team members.
  • Apply for project team member resources from the appropriate Line Manager upon contract award.
  • Conduct initial team meetings, developing project implementation and communication plans based on contract review.
  • Verify and ensure the accuracy and completeness of information entered into the management system.
  • Provide or organize project-related training for team members.
  • Prepare and update the master operating plan (SOP).
  • Develop project-related plans and trial-related forms, including project management, clinical monitoring, risk management, communication, recruitment, document management, and quality management plans.
  • Monitor and control the project schedule, ensuring adherence to plans, budget, and contract specifications.
  • Ensure compliance with protocol, SOP, ICH-GCP/China GCP, and relevant laws and regulations in all clinical operations and procedures.
  • Timely report safety events and related deviations according to protocol and regulatory requirements.
  • Calculate and apply investigational products at the project level, ensuring compliance with trial requirements.
  • Plan and conduct investigator meetings, ensuring desired outcomes.
  • Collaborate with the Data Manager to review and develop Case Report Forms (CRFs) in accordance with the trial protocol.
  • Hold regular team meetings to assign responsibilities, monitor project task schedules, and assess overall project status.
  • Review meeting minutes, internal and external correspondence, project-related reports, and ensure timely submission of project briefings to the Sponsor.
  • Ensure the timeliness, accuracy, and integrity of documents in the trial project's master file.
  • Conduct collaborative monitoring of trial sites, identifying and guiding resolution of site problems.
  • Maintain project resources, managing utilization at least monthly to optimize quality and revenue

Qualifications:

  • Degree in Medicine, Pharmacy, Life Science, or related specialities.
  • Proficiency in ICH-GCP, Chinese GCP, and relevant laws and regulations.
  • Experience of 3 phase I/II/III full lifecycle PM. Oncology experience is beneficial.
  • Minimum of 10 years of clinical trial-related work experience, with at least 8 years of clinical trial management experience, preferably at a CRO.
  • Proven revenue and cost management capability.

If you are a dedicated and experienced Clinical Project Manager looking to contribute to the success of global clinical projects, we invite you to join our team at Pharmaron.

Pharmaron USA is an equal opportunity employer, and we encourage applicants from all backgrounds to apply. We thank all applicants for their interest; however, only those selected for an interview will be contacted.

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