1. Act as SMT leader to provide direction and leadership to medical clinical studies
2. Lead one or more SMT to achieve successful study completion for all stage from planning to archive
3. Manage the Delivery of Study Activities in Order to Meet Study Plans
- Prepare and conduct vendor selection and quality oversight, review and approve Work order.
- Prepare study level contract and Inform consent form
- Finalize study master label for local study and set up rolling forecast plan,accountable for study IMP inventory and accountability
- Ensure AE/SAE reporting, SUSAR distribution according to Roche timeline and procedure
- Prepare and organize investigator meeting
- Timely update study progress in CTMS in study level
- Conduct TMF review per TMF quality plan
- Leads the oversight of CRO vendor activities by set up oversight plan and assess CRO performance activities by details describe in CRO oversight plan
- Monitor key performance indicators (KPI) and update clinical study dashboard by aligned KPI with following of resolve study related issues/risks/protocol deviation and non-compliance
- Ensure CTMS data quality in country level and study level, enhance CTMS compliance for full outsourcing study in both study and site level
- Ensure monitoring reports are timely submitted and reviewed according to CTMS business rule
- Conduct co-monitoring visits in align with CMV plan and follow up till all CAPA closed
- Work with QC closely CRO to ensure all compliance visit CAPA closed
- Ensure study expense is within reasonable variance of approved budget
- Conduct accrual according to finance policy every month, review and response for any discrepancy in time.
- Adjust study budget in T0/T3 according to company timeline
4. Develops and maintains effective working relationships with key stakeholders.
5. Provides the operational expertise and leadership to clinical operations teams to ensure the effective and efficient delivery of all operational aspects of regional study through all phases of study management (Start-up, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations (for Senior Role)
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