Clinical Trial Coordinator

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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.

📋 Description

• 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-specific documentation, team lists, training trackers, system access management, and project activity plans • Keep the (e)TMF up to date by following file review schedules and documenting findings • Provide system support for GoBalto and eTMF • Support RBM activities • Process documents sent to the Client (e)TMF, perform (e)TMF reviews, conduct mass mailings and communications, and provide documents and reports • Schedule and organize client and internal meetings and complete meeting minutes • Review and track local regulatory documents • Transmit documents to the client 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 compiling and distributing Investigator Site File and Pharmacy binder materials and non-clinical study supplies to sites • Assist with study-specific translation materials and translation quality control • Attend kick-off meetings and take notes when required • Act as a cross-functional liaison, onboarding buddy, trainer, and contributor to process improvement initiatives

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 4 years • Combination of appropriate education, training, and/or directly related experience may be considered as an equivalency • Bachelor's degree preferred • Ability to work in a team or independently • Strong organizational skills and attention to detail • Ability to manage multiple tasks efficiently and effectively • Ability to analyze project-specific data and systems for accuracy and efficiency • Strong customer focus • Flexibility and adaptability to changing project timelines • Good working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs • Excellent English language and grammar skills and 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

🏖️ Benefits

• Fully remote work arrangement • Potential occasional travel • Reasonable accommodation for individuals with disabilities • Benefits and privileges of employment