
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.
🔥 15 minutes 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 by ensuring files are reviewed according to organizational SOPs and department guidance. • Provide administrative support for site activation activities and aid development of 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. • Provide system support for Activate and eTMF and keep databases current. • Process and review eTMF documents, distribute communications, and provide documents and reports to internal team members. • Analyze and reconcile study metrics and findings reports. • Coordinate Investigator Site File and Pharmacy binder materials and non-clinical study supplies. • Support study-specific translation materials and translation quality control. • Review and track local regulatory documents and support regulatory submissions. • Coordinate client and internal meetings as needed. • Maintain study documentation, team lists, training requirements, system access, activity plans, vendor trackers, and contact information. • Work directly with sites to obtain site-selection documents and support site interest plans and survey responses. • Prepare regulatory compliance review packages. • Coordinate with internal departments to align site start-up activities with the activation critical path. • Communicate with clinical personnel regarding site issues and risks; escalate non-compliance. • Act as a local expert on site capacity and experience and contribute to identifying and developing new sites. • Liaise with Global Investigator Services to resolve investigator queries. • Contribute to global strategic feasibility processes and best practices. • Train new personnel in processes and systems.
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides 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, will be considered sufficient for an individual to meet the requirements of the role. • Ability to work in a team or independently as required • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency • Strong customer focus • Flexibility to reprioritize workload to meet changing project timelines • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout • Good English language and grammar skills and proficient local language skills as needed • Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems • Ability to successfully complete the organizations clinical training program • Self-motivated, positive attitude and good interpersonal skills • Effective oral and written communication skills • Essential judgment and decision-making skills • Capable of accurately following project work instructions • Good negotiation skills • Independent thinker • Ability to manage risk and perform risk escalation appropriately • Occasional drives to site locations; potential occasional travel required
• Fully remote work arrangement • Standard Monday–Friday work schedule
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