1. Act as SMT leader to provide direction and leadership to medical clinical studies
- Leader Study Manager Team (SMT) to ensure medical study was conduct with high standard with compliance of ICH GCP, Roche SOP and regulatory requirement
- Enhance SMT guidance with implementation to all medical study to provide local strategic planning
- Liaises with global SMT and international project manager and provides inputs for global/regional clinical trials
- Leads the SMT to ensures GLORA process is followed for LMA study
- Coaches, and provides indirect line management support in partnership with the relevant line managers to Roche in-house study team members (i.e. CTA, SSU,COBM, MM,LSR) by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow up to ensure team performance is fully optimized.
2. Lead one or more SMT to achieve successful study completion for all stage from planning to archive
- Establishes study project management package by set up study timelines, budget, resource, Risk manager and outsourcing strategy
- Provides feedback from an operational perspective into the study synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures
- Develop study management plan including but not limited to Trial Monitoring Plan ,TMF Quality Plan, Patient recruitment plan, Safety Management Plan,CMV Plan
- Ensure with quality oversight of study plan developed by SMT other function ,including but not limited to MMP, DMP ,SAP
- Ensure study recruitment on track per study/site recruitment plan
- Ensure the study conduct according to GCP ,Roche SOP and regulatory requirement in accordance with project timeline for key milestone
- Ensure the study CSR develop by SMT in time and with E3 standard
3. Manage the Delivery of Study Activities in Order to Meet Study Plans
- Set up SMT team chart with clearly Role & Responsibility
- Implement study procedure for site selection, site activation and site closeout with following of SOP. Accountable for timely achievement of key study milestones (EC approval, Site Activation, FPFV, LPFV, LPLV, DB lock, etc.
- 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
- Supervise the conduct of the study is in accordance with 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
- Oversee the study budget according to company policy
- 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
- Identifies areas of best practice and contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the function.
4. Develops and maintains effective working relationships with key stakeholders.
- Develop and maintain professional relationship with Sponsors, leading PIs and external investigators.
- Act as SMLT to maintain working relationship with internal 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)