Sr Clinical Project Manager

Princeton
14-10-2024
Job Type
Permanent
Emp Type
Full Time
Functional Expertise
Clinical Operations
Salary Type
Annual

Job Description

Objectives:

Management of regional / global multi-center oncology or autoimmune clinical studies, including oversight of clinical trials, developing the key clinical study document, internal and external communication, GCP inspection readiness, etc.

Job Responsibilities:

  • Management of regional / global multi-center oncology or autoimmune clinical studies.
  • In collaboration with the project director, defines, develops, and sets project timelines, budget, necessary procedures, staffing requirement and resources
  • Oversight of clinical studies, interacting with CRO, study vendors, and the investigators to ensure goals and objectives are accomplished within projected timeframes and budget requirements
  • Ensures efficient streamlined processes are in place to deliver study to plan and ensure safety of subjects and completeness/ integrity of data
  • Ensures development, review, finalization and delivery of high-quality key clinical study documents to meet study timelines
  • Accountable for study related communications and for resolution or escalation of operational issues with all related project members and departments
  • Reviews status reports and modifies project schedules and / or plans as required
  • Organizes and leads internal project meetings and participants in the investigator’s meetings
  • Performs monitoring visits as needed (e.g. quality assurance, audit preparation, etc.)
  • Prepares and presents project reports for management or others
  • Ensures adherence to Good Clinical Practice and all applicable local and international regulations
  • Involves in or support the communication with competent authorization
  • Supports the GCP inspection readiness

Qualifications and requirements:

  • Educated to degree level (biological sciences, pharmacy or other health related discipline preferred) or relevant experience in a medical / nursing field
  • At least 3 years of experience as a clinical project manager
  • Preferred experience in oncology or autoimmune diseases
  • Experience of monitoring clinical trials to ICH GCP
  • Excellent interpersonal, verbal, and written communication skill (in English)
  • Ability to motivate both individually and collectively
  • Excellent problem-solving capability through early identification; excellent computer literacy Occasional travel may be required
  • Fluency in Mandarin is a plus
  • Flexibility with work hours; night and early morning TC with corporate office in China

Consultant