
10,000+ employees
Founded 1956
🏥 Healthcare
📦 Logistics
🏭 Manufacturing
Healthcare • Logistics • Manufacturing
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
🔥 49 minutes ago
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10,000+ employees
Founded 1956
🏥 Healthcare
📦 Logistics
🏭 Manufacturing
Healthcare • Logistics • Manufacturing
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
• Coordinate, oversee, and complete assigned trial activities according to the task matrix • Perform department, internal, country, and investigator file reviews and document findings • Complete allocated tasks on time, within budget, and to quality standards • Provide system support for Activate and eTMF and maintain current databases • Process documents sent to the Client eTMF, perform eTMF reviews, distribute communications, and provide reports • Analyze and reconcile study metrics and findings reports • Assist with Investigator Site File and Pharmacy binder materials and study supplies • Support translation materials and translation quality control • Maintain knowledge of SOPs, client directives, and regulatory guidelines • Support client and internal meeting scheduling • Review and track local regulatory documents • Support RBM activities and study-specific documentation and systems • Transmit documents to the client and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and site start-up activities • Obtain site-selection documents directly from sites • Prepare regulatory compliance review packages • Complete Site Interest Plans in CTMS and collect associated documents • Document site communications, follow-ups, and survey responses in real time • Review survey data for logical, complete, and accurate responses • Collaborate with teammates and clinical personnel regarding site issues and risks • Maintain site-contact plans and escalate concerns or non-compliance • Provide local expertise on site capacity and experience and recommend additional sites • Resolve investigator queries and maintain account and contact information • Contribute to global feasibility processes and best practices • Train new personnel in processes and systems • Contribute local knowledge to identifying and developing new sites • Conduct on-site feasibility visits where applicable in Asia Pacific • Occasional driving to site locations and potential travel
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 0 to 1 year • Bachelor's degree preferred • Equivalent combination of appropriate education, training and/or directly related experience may be considered • Ability to work in a team or independently • Good organizational skills and strong attention to detail • Ability to handle multiple tasks efficiently and effectively • Ability to analyze project-specific data/systems for accuracy and efficiency • Strong customer focus • Flexibility to reprioritize workload • Knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs • Good English language and grammar skills and proficient local language skills as needed • Proficiency in MS Office (Word, Excel, and PowerPoint) • Ability to learn and master clinical trial database systems • Ability to complete the organization's clinical training program • Effective oral and written communication skills • Judgment and decision-making skills • Ability to follow project work instructions accurately • Good negotiation skills • Ability to manage risk and perform risk escalation appropriately
• Fully Remote work arrangement • Standard Monday–Friday work schedule
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