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 participates 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 supports 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 skills (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.
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