
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.
🔥 17 hours 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.
• Provide administrative and technical support to the Project Team • Support audit readiness through scheduled department, internal, country, and investigator file reviews • Coordinate, oversee, and complete assigned trial activities according to the task matrix • Support site activation activities and development of site activation critical paths • Develop and review site lists for feasibility activities and contribute to local site tiering • Ensure assigned tasks are completed on time, within budget, and to quality standards; communicate risks to project leads • Provide system support for Activate and eTMF and keep databases current • Process documents to the client eTMF, perform eTMF reviews, distribute communications, and provide reports • Analyze and reconcile study metrics and findings reports; help resolve site documentation findings • Coordinate Investigator Site File and Pharmacy binder materials, non-clinical supplies, and translation materials • Maintain knowledge of applicable SOPs, client directives, and regulatory guidelines • Conduct on-site feasibility visits where applicable (Asia Pacific only) • Support client/internal meeting scheduling and tracking of local regulatory documents • Support RBM activities and study documentation, training requirements, system access, and project activity plans • Transmit documents to the client and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and site selection document collection • Prepare regulatory compliance review packages • Coordinate with internal departments to align site start-up activities with the activation critical path • Complete Site Interest Plans in CTMS and collect associated investigator/site personnel documents where applicable • Document 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 deadlines, site issues, and risks • Ensure effective site contact and follow-up plans, escalating concerns or non-compliance • Serve as local expert on site capacity and experience, recommend additional sites, and support local 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 • Use local knowledge to identify and develop new sites • May act as a buddy during onboarding
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • Previous experience comparable to 0 to 1 year • Equivalency through a 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 according to changing project timelines • 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 • Proficiency in MS Office (Word, Excel, and PowerPoint) and ability to learn clinical trial database systems • Ability to complete the organization's clinical training program • Self-motivated with a positive attitude and good interpersonal skills • Effective oral and written communication skills • Essential judgment and decision-making skills • Ability to accurately follow project work instructions • Good negotiation skills • Independent thinking • Ability to manage risk and perform appropriate risk escalation • Occasional drives to site locations and potential occasional travel
• Fully remote work arrangement • Standard Monday–Friday work schedule
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