
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.
🕒 July 29
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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 • Ensure allocated tasks are completed on time, within budget, and to a high-quality standard • Provide system support for Activate and eTMF and keep system databases current • Process documents for Client eTMF, perform eTMF reviews, distribute communications, and provide reports • Analyze and reconcile study metrics and findings reports • Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Support study-specific 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 risk-based monitoring activities • Maintain study documentation, team lists, training requirements, system access, and activity plans • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and site start-up activities • Work directly with sites to obtain site-selection documents • Prepare regulatory compliance review packages • Coordinate site activation activities with internal departments • Complete Site Interest Plans and collect investigator/site personnel documents when applicable • Document site communications, follow-ups, and survey responses in real time • Review survey data for logical, complete, and relevant responses • Collaborate with teammates and clinical personnel regarding site issues and risks • Maintain site contact and follow-up plans and escalate non-compliance • Provide local expertise on site capacity and experience and recommend additional sites • Resolve investigator queries with Global Investigator Services and maintain account/contact information • Contribute to global feasibility processes and best practices • Train new personnel in processes and systems • Use local knowledge to identify and develop new sites
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • Previous experience comparable to 0 to 1 year • 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 • Working 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 • Proficient in MS Office (Word, Excel, and PowerPoint) • Ability to learn and master clinical trial database systems • Ability to successfully complete the organization's clinical training program • Effective oral and written communication skills • Essential judgment and decision-making skills • Ability to accurately follow project work instructions • Good negotiation skills • Ability to manage risk and perform risk escalation appropriately
• Fully remote work arrangement • Standard Monday–Friday work schedule • Potential occasional travel • Training provided for new personnel and clinical training program
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