Senior Clinical Trial Manager

Job not on LinkedIn

🔥 48 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

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

• Accountable for achieving the final start-up and clinical deliverables within the time period specified in the contract with the customer • Manages 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 in conjunction with the study requirements and Data Quality Plan • Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File • Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained • Responsible for the implementation and training of standardized clinical monitoring processes within the study • Ensures achievement of the start-up and clinical deliverable within the contractual time period specified by preparing and monitoring start-up and clinical activity timelines and metrics • May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials • Coordinates all start-up activities and ensures that essential document quality meets the expectation of Regulatory Compliance Review

🎯 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 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 • Strong financial acumen and knowledge of budgeting, forecasting and fiscal management

🏖️ Benefits

• continued career advancement opportunities • award winning training • benefits focused on the health and wellbeing of our employees