美捷國際有限公司

Job Summary Medpace is currently looking for a Clinical Trial Manager (CTM) to lead global clinical research studies. Medpace is a scientifically led organization offering full-service solutions for our clients, giving the Medpace project teams the empowerment to truly lead and execute clinical trials. The Clinical Trial Manager position is the lead role for multiservice global/regional clinical trials. The CTM interacts with sponsors and sites and manages the timeline and project deliverables (minus finance). This role coordinates all services contracted for the study, leading the cross functional team thru all life cycles of the project (from startup to database lock and closure). CTM will attend bid defense meetings and support business development activities, as needed. This position is office based. Responsibilities •Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations •Serve as primary Sponsor contact for project-specific issues and study deliverables •Maintain in depth knowledge of protocol, therapeutic area, and indication •Provide cross-functional oversight of project team members and deliverables, which includes ensuring all necessary project-specific training is provided •Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable •Develop operational project plans •Manage risk assessment and mitigations •Manage study vendors •Manage site quality, including direct supervision of project Clinical Research Associates (CRA) and monitoring deliverables

Job Summary Medpace is a leading CRO for Biotech companies and we are currently seeking candidates with PhDs and/or Post-Doctoral Research experience for a full-time, office-based Associate Clinical Trial Manager (aCTM) to join our Clinical Trial Management team in our Taiwan office. The aCTM will be a part of the Clinical Trial Management team and support Project Coordinators and Clinical Trial Managers in performance of project management activities. Candidate must have a desire to transfer and apply analytical and academic skills in clinical project administration and management. This is a fantastic opportunity for recent PhD graduates to enter the industry, receive solid foundational training, work in an international environment, and develop their career in the research and development of cutting-edge therapeutics. Candidates should expect to have an intensive training period and show the desire and aptitude for an accelerated career path into Clinical Trial Management (CTM). Responsibilities •Communicate and collaborate on global study activities; working closely with the project coordinator and clinical trial manager; •Ensure timely delivery of recurrent tasks consistently with a high degree of accuracy; •Compile and maintain project-specific status reports within the clinical trial management system; •Interact with the internal project team, Sponsor, study sites, and third-party vendors; •Provide oversight and quality control of our internal regulatory filing system; •Provide oversight and management of study supplies; •Create and maintain project timelines; and •Coordinate project meetings and produce quality minutes.

Job Summary We are currently seeking a full-time, office-based Clinical Research Project Coordinator to join our Clinical Trial Management team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities •Engage in clinical trial management on a day to day level; •Work closely with the project CTM for timely delivery of recurrent tasks consistently with a high degree of accuracy; •Compile and maintain project-specific status reports; •Update CTMS with study milestones, enrolment projections etc. •Update eTMF and perform ongoing eTMF QC; •Support clinical trial manager to draft study plans and study specific guidance documents; •Manager site feasibility, site activation preparation and study supply managements; •Communicate with regional cross functional team, vendors and sponsor effectively;

Job Summary Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Experienced Site Payments Analyst to join our Clinical Operations team. This position plays a critical role within Clinical Operations by providing project-level support with the processing of investigator grant (IG) payments, as well as supporting the monthly/quarterly Investigator Grant (IG) Revenue Recognition (Rev Rec) process, which includes the estimation, analysis, and forecasting of IG revenue/expenses. This role will also support the company’s continued growth through generation of IG budgets for new projects via the Request for Proposal (RFP) process. We are looking for detail-oriented, self-motivated individuals who are seeking an opportunity to further their analysis experience while contributing to strategic initiatives that will provide benefits across the company. Responsibilities •Develop, maintain, and analyze IG cost estimates/budgets for Phase I-IV clinical research projects from Request for Proposal (RFP) through project completion; •Coordinate the calculation of periodic payments to investigators; •Manage monthly/quarterly IG project evaluation, including estimating, analyzing, and forecasting IG revenue/expenses by project in support of company revenue recognition; •Provide oversight and development to junior analysts; •Prepare and analyze various KPI reports for trends and escalate noted items for resolution; and •Work cross-functionally with many departments at Medpace to fulfill internal and external requests.

Job Summary We are currently seeking a full-time, office-based Clinical Safety Coordinator to join our team in Taiwan office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise, develop and grow your career even further, then this is the opportunity for you. Responsibilities • Working closely with the Clinical Safety Manager to ensure each project deliverables are met; • Collect, process, and track serious adverse event (SAE) reports and clinical event documents; • Generate and track study report safety narratives; • Coordinate safety surveillance activities (e.g., lab review and trend analysis); • Generate Investigator Safety Letters and distribution to health authority; • Assist in preparation of clinical safety documents • Perform safety submissions of expedited/periodic reports in Singapore/Taiwan/China

Job Summary We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in the Taiwan office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company's success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Responsibilities •Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; •Prepare, review, and submit to Regulatory Agencies; •Communicate with global study teams and personnel on study progress; •Ability to effectively identify risks to site activations and mitigate as necessary; •Provide expertise and guidance to global study teams in ethics and regulatory submissions; •Review and finalize essential documents required for site activation; •Act as a main contact for Ethical and Regulatory submission-related activities; •Direct contact with investigative sites during the study start up and activation process; •Ensure submissions comply with applicable regulations and guidance documents; •Advise sponsors on changing regulations and compliance requirements; and •Track submissions and ensure timely filing of documents.

Job Summary Due to our continued growth, we are in need of a qualified, Office Assistant (Finance) for a vital role in our Facilities department. This position will be a full-time, office-based position in Taiwan, Taipei. Responsibilities • For all responsibilities below, the incumbent will be supporting the Taiwan office; • Provides support for local and office administration; • Supports financial administration for Taiwan and other countries including processing incoming invoices, office expenditures, providing detailed information and processing payments accordingly; • Track, process, and organize various documents, supplies, shipments, samples, invoices, transactions, and communications, as necessary; • Provides support for local office administration, including but not limited to Purchasing, HR, logistics, IT, and Finance; • May be responsible for other projects and responsibilities as assigned.