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.
Qualifications
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
