
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 critical-path development • 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 to project leads • Provide system support for Activate and eTMF and maintain current databases • Process documents to client eTMF, perform eTMF reviews, distribute communications and provide reports • Analyze and reconcile study metrics and findings reports • Coordinate and distribute Investigator Site File, pharmacy binder materials and study supplies • Support translation materials and translation quality control • Support feasibility visits, meetings, regulatory-document tracking, RBM activities and study documentation systems as applicable • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers and support regulatory submissions • Obtain site-selection documents directly from sites • Prepare regulatory compliance review packages • Coordinate with internal departments to align site start-up activities • Complete Site Interest Plans and collect associated investigator/site documents as 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 regarding site issues, risks and deadlines • Ensure site-contact plans are followed 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 • Utilize local knowledge to identify and develop new sites
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Previous experience 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 • Proficiency in MS Office (Word, Excel, and PowerPoint) • Ability to learn 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
• Fully remote work arrangement • Standard Monday–Friday work schedule
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