Trial Delivery Specialist – Clinical Trial Coordinator

🕒 September 17

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 18%

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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 electronic Trial Master File (eTMF) up to date and document review findings • Provide system support, including GoBalto and eTMF • Support risk-based monitoring (RBM) activities • Process documents for the client eTMF, perform eTMF reviews, mass mailings and communications, 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 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 • Coordinate, compile and distribute 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 and potential study lead • Support onboarding as a buddy and train new staff as needed • 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 • At least 4 years of previous experience providing the knowledge, skills, and abilities to perform the job • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Ability to work in a team or independently • Strong organizational skills and attention to detail • Proven ability to handle multiple tasks efficiently and effectively • Ability to analyze project-specific data/systems for accuracy and efficiency • Strong customer focus • Flexibility and adaptability to reprioritize workload • Knowledge of applicable Country Regulations, ICH Good Clinical Practices, 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 (Word, Excel, and PowerPoint) • Ability to learn 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 • Standard Monday–Friday work schedule

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