
10,000+ employees
Founded 1956
đĽ Healthcare
đŚ Logistics
đ 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
đĽ Healthcare
đŚ Logistics
đ 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 ⢠Ensure allocated tasks are completed on time, within budget, and to a high quality standard ⢠Communicate project risks to project leads and line manager ⢠Maintain study documentation, team lists, training trackers, system access, activity plans, and eTMF records ⢠Provide GoBalto and eTMF system support ⢠Support risk-based monitoring activities ⢠Process documents, perform eTMF reviews, conduct mass mailings, and provide reports to internal team members ⢠Schedule and organize client/internal meetings and complete meeting minutes ⢠Review and track local regulatory documents ⢠Transmit documents to clients and centralized IRB/IEC ⢠Analyze and reconcile study metrics and findings reports ⢠Assist with clarification and resolution of site documentation findings ⢠Maintain vendor trackers ⢠Assist with Investigator Site File and Pharmacy binder materials and study supplies ⢠Assist with translation materials and translation quality control ⢠Attend kick-off meetings and take notes when required ⢠Act as a cross-functional liaison and potentially serve as a study lead ⢠Support onboarding as a buddy and provide training to new staff ⢠Support departmental and cross-functional process improvement initiatives
⢠High / Secondary school diploma or equivalent and relevant formal academic/vocational qualification ⢠Bachelor's degree preferred ⢠At least 4 years of comparable experience ⢠Ability to work independently or in a team ⢠Strong organizational skills and attention to detail ⢠Ability to manage multiple tasks efficiently and effectively ⢠Ability to analyze project-specific data and systems ⢠Strong customer focus ⢠Flexibility and adaptability to changing project timelines ⢠Working knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs, and WPDs ⢠Excellent English language and grammar skills ⢠Proficient local language skills as needed ⢠Good presentation skills ⢠Proficiency in MS Office, including Word, Excel, and PowerPoint ⢠Ability to learn and master clinical trial database systems ⢠Ability to successfully complete the PPD clinical training program ⢠Self-motivated, positive attitude, and strong interpersonal skills ⢠Occasional drives to site locations and potential occasional travel
⢠Fully remote work arrangement ⢠Potential occasional travel ⢠Accessibility/disability accommodations in the application and interview process ⢠Benefits and privileges of employment, with reasonable accommodation where needed
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