临床项目管理总监(J18666)

职位描述

· Ensure appropriate monitoring oversight plans are in place and reflect adequate adherence to all relevant regulations including GCP, ICH, local regulatory requirements, as well as SOPs and policies.

· Lead in study planning to ensure appropriate study timeline, budget and resource are in place.

· Obtain appropriate and sufficient resources as required for the studies.

· Lead the clinical core team in executing of study tasks in according to the study plan.

· Lead the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with key stakeholders within the Study Management Team(SMT).

· Oversee CRO in executing clinical operations related activities from study setup, sites startup, enrollment, study maintenance, interim/final analyses, study closeout, clinical study reports, annual reports, and other clinical documents.

· Monitor Key Performance Indicators (KPIs) and study metrics to track the quality and performance of the studies.

· Provide study status reports and study presentations to management team.

· Oversee closely on study progress, study budget, study timeline.

· Identify quality and deliverable risks, roll mitigation plans together with the relevant stakeholders, to ensure risks are minimized.

· Ensure the study team provide timely and appropriate response and resolution to study management issues

· Establish good working relationships with participating sites and be the point of sponsor contact on escalated site issues.

· Lead Clinical operations activities such as site identification, site selection, study startup, site activation, Investigator Meeting Organization, Site Engagements and Booster Visits, and study closeout.

· Conduct regular monitor assessment visits to ensure sites are well monitored and managed by the assigned CRAs.

· Support site inspections and audits.

任职要求

· Bachelor's degree (or equivalent) or above in Clinical medicine, pharmacy, biology, nursing, and other field related to human study

· With at least 15 years of relevant working experience in clinical operations and/or clinical project management field, with at least 8 years of global trial management.

· Familiar with GCP, NMPA regulations, ICH-GCP regulations, and other drugs' clinical trial quality management specifications.

· Experience in clinical project supplier management, project management, financial management, and quality control.

· Experience in managing global studies from Phase I to III.

· Demonstrate proficiency in ICH rules, regulations from key global regulators such as FDA and NMPA, as well as relevant clinical trial guidelines governing conduct of clinical studies

· Extensive experience in oncology drug development, especially in immuno- oncology is an added advantage