This role is for upcoming future opportunities that may arise at Fortrea. Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer. *Mandatory Core tasks for F-CTC: 1. Ability to collaborate with finance/budgeting representatives to develop country and site budgets (including split site budgets) 2.Experience tracking and reporting budget negotiations, and maintaining tracking tools in collaboration with the finance/budget representatives 3.Working knowledge of contract development, negotiation, approval, and maintenance (e.g. CTRAs) 4.Experience updating and maintaining contract templates (in cooperation with Legal Department) 5. Experience with payment calculation and execution (investigators, vendors, grants) 6. Experience monitoring and tracking adherence and disclosures 7. Experience with budget closeout You will need following experience: 1.Experience with trial and site administration: for example, tracking essential documents and safety reporting. 2.Experience collating, distributing, and archiving study tools and documents. 3.Experience using clinical trial databases (CTMS) and study trackers. 4.Experience with clinical supply and non-clinical supply management, in collaboration with other country roles. 5.Experience managing labeling requirements, and coordinating/signing translation change requests. 6.Experience preparing study documents, and corresponding with sites and clinical trial team. 7.Experience assisting with eTMF reconciliation. 8.Experience updating manuals/documents (e.g. patient diaries, instructions). 9.Experience documenting proper destruction of clinical supplies. 10.Experience preparing Investigator trial file binders. 11.Experience executing eTMF Quality Control Plan. 12.Experience obtaining translations of documents. 13.Experience providing and collecting from investigators forms/lists for site evaluation/validation, site start-up and submissions. 14.Experience obtaining, tracking, and updating study insurance certificates. 15.Ability to support preparation of submission package for IRB/ERC and support regulatory agencies submissions. 16.Ability to collaborate with finance/budgeting representatives to develop country and site budgets (including split site budgets). 17.Experience tracking and reporting budget negotiations, and maintaining tracking tools in collaboration with the finance/budget representatives. 18.Working knowledge of contract development, negotiation, approval, and maintenance (e.g. CTRAs). 19.Experience updating and maintaining contract templates (in cooperation with Legal Department). 20.Experience with payment calculation and execution (investigators, vendors, grants) 21.Ability to ensure compliance with financial procedures. 22.Experience with budget closeout. *Experience/Education/Qualifications: 1. B.A./B.S. (Life Science preferred) or equivalent healthcare experience. 2. Minimum 2 years working expereince in global pharma/CRO. If local pharma/CRO experience will have 0.5 adjustment of the working experience. 3. Fluent in Local Languages and business proficient in English (verbal and written). 4. Excellent communication skills. 5. Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. 6. Hands on knowledge of Good Documentation Practices. 7. Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required. 8. ICH-GCP Knowledge appropriate to role.
待遇面議
(經常性薪資達 4 萬元或以上)
Responsibilities/Duties: Under CTC’s role, you will be responsible for study start up and financial/submission operations for assigned protocols in compliance with ICH/GCP and country regulations, company policies and procedures and with quality standards internally and externally. You will work closely with CRAs, COMs and CRMs to ensure study related financial/ submission completed in timely manner or ahead of plans and also achieve study country/site milestones.
完善的福利 ■ 勞保與團保100%由公司給付,補助部分家人公司團保福利 ■ 彈性工時與彈性工作地點,可遠端在家工作 ■入職即享14天特休,帶薪病假30天 ■全天候供應研磨咖啡、茶包 ■ 免費定期年度健康檢查 ■ 旅遊津貼、中秋端午禮金、特殊節日禮品 ■ 健保、勞保退休金提撥 免費且豐富的學習資源 ■ 員工可視個人學習需求,免費提供關鍵職能課程,提升員工跨部門溝通合作力、個人領導力、工作效率、專案管理、管理領導、英文等能力 多元的發展 ■ 以內部的職能發展系統為輔助,制定短期與中長期的發展與學習規劃 ■ 提供多元的職涯發展路徑 ■ 提供透明的內部職缺資訊