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, systems, tools, trackers, and (e)TMF records • Provide GoBalto and eTMF system support • Support RBM activities • Perform trial administration, including document processing, (e)TMF reviews, mass mailings, communications, and reporting • 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 Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Assist with study-specific translation materials and translation quality control • Attend kickoff meetings and take notes when required • Act as a cross-functional liaison and potential study lead • Support onboarding by acting as a buddy and training new staff • Support departmental and cross-functional process improvement initiatives

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • Previous experience comparable to at least 4 years • Combination of appropriate education, training, and/or directly related experience may be considered as an equivalency • 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, and organization/client SOPs and WPDs • Excellent English language and grammar skills and proficient local language skills as needed • Good presentation skills • Excellent computer skills and 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 required

🏖️ Benefits

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