
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.
• Provide administrative and technical support to the Project Team • Support audit readiness through scheduled file reviews according to SOPs and department guidance • Provide administrative support for site activation activities • Aid development of site activation critical paths • Develop and review site lists for feasibility activities and contribute local input to site tiering • 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; communicate risks • Support Activate and eTMF systems and maintain current databases • Process and review trial documents, distribute mailings and communications, and provide reports • Analyze and reconcile study metrics and findings reports • Coordinate Investigator Site File and Pharmacy binder materials and study supplies • Support translation materials and translation quality control • Support client/internal meeting scheduling and regulatory document tracking • Support RBM activities and study documentation/system maintenance • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and prepare regulatory compliance review packages • Work with sites to obtain site-selection documents • Coordinate internal departments to align site start-up activities with activation critical paths • Complete Site Interest Plans 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 relevant responses • Collaborate with teammates and clinical personnel on deadlines, site issues, and risks • Ensure site-contact and follow-up plans are implemented; escalate concerns and non-compliance • Provide local expertise on site capacity and experience, recommend additional sites, and support site tiering • 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 • Utilize 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 providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 1 year • Ability to work independently or in a team • Strong organizational skills and attention to detail • Ability to manage multiple tasks efficiently and effectively • Ability to analyze project-specific data/systems accurately • Strong customer focus • Flexibility to reprioritize workload • Working knowledge of applicable country regulations, ICH Good Clinical Practices, 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 • Negotiation skills • Ability to manage risk and perform risk escalation • Occasional travel and drives to site locations may be required
• Fully remote work arrangement • Standard Monday–Friday work schedule
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