Senior Clinical Trial Manager – Sr CTM

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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

• Manage all clinical and start-up activities, operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP • Acts as the primary point of contact for study start-up activities and site activation across the assigned region and/or globally, driving timelines and ensuring operational excellence • Develops start-up and clinical tools (e.g. Essential Document Checklist, Monitoring Plan, Monitoring Guidelines) in conjunction with the study requirements and Data Quality Plan • Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings • Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) • Strong experience managing end-to-end clinical trial start-up (SSU) activities, particularly within the APAC region • Experience leading cross-functional collaboration with CAS, RAL, ICF PM, GCS, Contract Management, and other stakeholders to ensure seamless study execution • Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams • Strong planning and organizational skills to enable effective prioritization of workload and workload of team members • Strong interpersonal and problem-solving skills to enable working in a multicultural matrix organization • Solid understanding of change management principles • Comprehensive understanding of the practices, processes, and requirements of start-up and clinical monitoring • Strong judgment, decision making, escalation, and risk management skills • Effective oral and written communication skills, including English language proficiency • Capable of evaluating own and team members workload against project budget and adjust resources accordingly • Strong financial acumen and knowledge of budgeting, forecasting and fiscal management • Strong attention to detail • In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. • Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. • Capable of independently managing clinical only studies

🏖️ Benefits

• Continued career advancement opportunities • Award winning training • Benefits focused on the health and wellbeing of our employees