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工作職責(zé): This position’s main responsibility is project management in accordance with company’s policies, sponsor contract/requirements under applicable laws and regulations. This position routine work is plan and Lead the Delivery of all components of a clinical study to time, cost, and quality from study specifications through study closeout activities and/or new drug/product approval by authority accordance with signed company contract with the sponsor. 1. Study delivery ? Planning and leading the delivery of all components of a clinical study to time, cost, and quality per company policies and contract with the sponsor ? Conduct clinical study management related work according to company Standard Operation Procedures (SOP), Good Clinical Practice (GCP), and other authority laws and regulations ? Form a motivated and aligned study team that delivers the study results on or ahead of agreed timeline with high quality & cost-effective ? Work with Line Managers/other managers to identify resource need and secure resources from clinical operations and/or various departments ? Prepare and deliver study execution strategy, including setting study milestone/timelines, develop recruitment strategies, quality control strategies, cost control strategies ? Leading/preparing/contributing/training to the delivery of Clinical Study Protocol, and delivery of other study documents (e.g. Protocol amendments, inform consent form/amendments, site feasibility/selection package files, EC package files, other study files, etc.) ? Produce study trackers, tools, forms and other study specific documents per study needs ? Proactively identify risks to the project, escalate as appropriate and follow through to resolution, develop &manage contingency risk plans to assure timely delivery to quality, budget & time and escalate issues to stakeholders as appropriate ? Leading/managing/contributing/discussing with internal/external study team/members/stakeholder for study status sharing, study reporting, study plan making, documents drafting, issues escalading/resolving/tracking until closed, and/or other stakeholders related activities ? Leading/deciding/participating in the negotiations and selection process of external service providers/vendors per study needs ? Contributes in steering committees, submission assembly teams, regulatory defence teams, contribute to Advisory Boards, and other activities regarding study, if needed ? Develop project management plan from time, quality and cost aspect per company policies and/or sponsor requirements ? Leading/Supporting/approving site selection, initiation, monitoring, and closure activities ? Leading/Supporting/approving study negotiation of budgets and site contracts, if applicable ? Plan, lead and ensure appropriate training is achieved at Investigator/monitor meetings ? Leading/contributing study trainings to team member in specific therapeutic areas, disease, protocol and other study specific processes per study needs ? Track and manage the assigned studies, work closely with study team member to manage the planning, preparation, execution, and reporting of clinical trials ensuring the time, quality, cost & consistency and integrity of data and safety of the subjects ? Focus on end results to be achieved, using metrics, key performance indicators and/or other tools to manage individual and team performance within clinical studies ? Review/approve CRA's monitoring visit reports, conduct accompany site visit, guide/coach CRA resolve issues and other activities during study executions from time, quality, cost perspectives ? Leading/tracking/managing the study Trial Master Files (TMF) were timely and appropriate collected, archived and transfer to sponsor per study requirements ? Leading/tracking/managing the study budget/cost were appropriate applied, arranged, forecasted, paid, invoice collection base on aligned with sponsor and/or company policies ? Acting as monitor per business/clinical trial needs to improve whole team/individual capabilities, efficiency, a clinical trial execution, quality, process initiatives and/or other purposes, if needed ? Conduct any other activities regarding study delivery or line manager assigned 2. Admin works and others ? Participate in Bidding activities and prepare presentation for clinical operation part if necessary ? Interacting with CRM/CTA lead/others for sharing/improving whole team/individual performance/capability and/or other purposes ? In liaison with Line Managers to support individual professional development through mentoring, training and other methods ? Work with other members of the organization to share knowledge, experiences and best practices ? Contributing/leading the whole function develop, quality, process optimization and/or other initiatives, if applicable ? Evaluate application rationality and approve/reject subordinator’s business travel application, and/or other activities per company policies and clinical trials needs ? Conduct any other activities which line manager assigned