
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.
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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 databases current • Process and review trial documents, distribute communications, and provide reports to internal team members • 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 meeting scheduling, local regulatory document tracking, RBM activities, documentation, access management, and activity plans • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers and support regulatory submissions • Work directly with sites to obtain site-selection documents • Assist with regulatory compliance review packages and site activation activities • Complete Site Interest Plans in CTMS and collect associated investigator/site documents when applicable • 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 to meet deadlines and manage site issues and risks • Develop and enforce site contact and follow-up plans, escalating concerns or non-compliance • Provide local expertise on site capacity, experience, tiering, and identification of new sites • Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information • Contribute to global feasibility processes and best practices • Train new personnel in processes and systems
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 0 to 1 year • Bachelor's degree preferred • Good English language and grammar skills and proficient local language skills as needed • Proficient in MS Office (Word, Excel, and PowerPoint) • Ability to obtain knowledge and master all clinical trial database systems • Ability to successfully complete the organization's clinical training program • Knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs • Ability to accurately follow project work instructions • Ability to manage risk and perform risk escalation appropriately • Occasional drives to site locations and potential occasional travel required
• 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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