
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 • Support site activation activities and 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 task matrices • Perform department, internal, country, and investigator file reviews and document findings • Complete allocated tasks on time, within budget, and to quality standards; communicate risks to project leads • Support Activate and eTMF systems and keep databases current • Process and review eTMF documents, distribute communications, and provide documents and reports • Analyze and reconcile study metrics and findings reports • Coordinate Investigator Site File, Pharmacy binder, and non-clinical study supply materials • Support translation materials and translation quality control • Conduct on-site feasibility visits where applicable in Asia Pacific • Schedule client and internal meetings as needed • Review and track local regulatory documents • 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 prepare regulatory compliance review packages • Work with sites to obtain site-selection documents • Coordinate with internal departments to align site start-up activities • Complete Site Interest Plans and collect associated investigator and site personnel documents • 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 to meet deadlines and resolve site issues and risks • Manage site contact and follow-up plans and escalate concerns or non-compliance • Provide local expertise on site capacity and experience and recommend additional 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 • Use local knowledge to identify and develop new sites
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 1 year • Bachelor's degree preferred • 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, 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 • Judgment and decision-making skills • Ability to follow project work instructions accurately • Good negotiation skills • Ability to manage risk and perform risk escalation appropriately • Occasional travel and drives to site locations may be required
• Fully remote work arrangement • Standard Monday–Friday work schedule • Training and onboarding support • Opportunity to act as a buddy and train new staff • Potential professional development through clinical training program
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