
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.
• 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 a high-quality standard; communicate risks to project leads • Provide system support for Activate and eTMF and keep databases current • Process documents for client eTMF, perform eTMF reviews, distribute mass mailings and communications, and provide documents and reports • Analyze and reconcile study metrics and findings reports • Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Assist with study-specific translation materials and translation quality control • Maintain knowledge of SOPs, client directives, and regulatory guidelines • Conduct on-site feasibility visits where applicable for Asia Pacific roles • Support client and internal meeting scheduling • Review and track local regulatory documents where applicable • Support risk-based monitoring activities • Maintain study documentation and systems, including team lists, training requirements, system access, and activity plans • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions • Work with sites to obtain site-selection documents • Assist with 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 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 regarding deadlines, site issues, and risks • Maintain an effective site-contact and follow-up plan 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 and 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 • Bachelor's degree preferred • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 1 year • In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient • Ability to work in a team or independently as required • Good organizational skills and strong attention to detail, with 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 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 accurately follow project work instructions • Negotiation skills • Ability to manage risk and perform appropriate risk escalation • Potential occasional travel and occasional drives to site locations
• Fully remote work arrangement • Standard Monday–Friday work schedule
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