职位描述:

1. Management of regional/global multi-center oncology or autoimmune clinical studies.

2. In collaboration with Project Director, defines, develops, and sets project timelines, budget, necessary procedures, staffing requirements and resources.

3. 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.

4. Ensures efficient streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness/integrity of data.

5. Ensures development, review, finalization, and delivery of high-quality key clinical study documents to meet study timelines.

6. Accountable for study related communications and for resolution or escalation of operational issues with all related project members and departments.

7. Reviews status reports and modifies project schedules and/or plans as required.

8. Organizes and leads internal project meetings and participates in Investigator’s Meetings.

9. Performs monitoring visits as needed (e.g. Quality assurance, audit preparation, etc.)

10. Prepares and presents project reports for management or others.

11. Ensures adherence to Good Clinical Practice and all applicable local and international regulations.

任职条件:

1. Educated to degree level (biological sciences, pharmacy or other health related discipline preferred) or relevant experience in a medical/nursing field.

2. At least 3 years of experience as a Clinical Project Manager.

3. Preferred experience in Oncology or autoimmune diseases.

4. Experience of monitoring clinical trials to ICH/GCP

5. Excellent interpersonal, verbal, and written communication skills (in English)

6. Ability to motivate both individually and collectively

7. Excellent problem-solving capability through early identification.

8. Excellent computer literacy

9. Travel may be required.