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