
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.
• 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 and help develop site activation critical paths • Develop and review site lists for feasibility activities and provide local input into 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 • Ensure allocated tasks are completed on time, within budget and to a high-quality standard; communicate risks to project leads • Support Activate and eTMF systems and keep databases current • Process documents to the Client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports • Analyze and reconcile study metrics and findings reports; assist with resolving site documentation findings • 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 applicable regulatory guidelines • Conduct on-site feasibility visits where applicable for Asia Pacific roles • Support client and internal meeting scheduling, local regulatory document tracking, RBM activities, study documentation, training requirements and system access management • Transmit documents to the client 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 coordinate with internal departments on site start-up activities • Complete Site Interest Plans in CTMS and collect associated investigator/site personnel documents where 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 to meet deadlines and address site issues and risks • Ensure site contact and follow-up plans are implemented; escalate concerns and non-compliance • Act as a local expert on site capacity and experience and identify, develop and tier 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 • Act as a buddy during onboarding and 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 • Equivalency may consist of a combination of appropriate education, training and/or directly related experience • 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, 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 master clinical trial database systems • Ability to complete the organization's clinical training program • Self-motivated, positive attitude and good interpersonal skills • Effective oral and written communication skills • Essential judgment and decision-making skills • Ability to follow project work instructions accurately • Good negotiation skills • Independent thinking • Ability to manage risk and perform risk escalation appropriately
• Fully remote work arrangement • Standard Monday–Friday work schedule
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