Senior Clinical Trial Manager, FSP

Job not on LinkedIn

October 24

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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Thermo Fisher Scientific

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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.

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. • Interprets data on complex issues and makes good business decisions with support from line management. • Ensures that all clinical deliverables meet the customer's time/quality/cost expectations. • Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. • Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. • Ensures efficient and thorough study start-up. • Supports the Clinical CRO in the training of the CRAs on all study specific operational activities. • Collaborates with the project manager to prepare, organize, and present at client meetings. • Responsible for the implementation and training of standardized clinical monitoring processes within the study. • Responsible for timely regulatory submissions (if appropriate).

🎯 Requirements

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) • 1+ year of leadership responsibility • MUST HAVE previous experience in both on site monitoring & in a CTM role • Rare Disease Experience is HIGHLY preferred • Exemplary mentoring/leadership/supervisory skills • Excellent clinical trials monitoring skills; ideally remote AND onsite experience • Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations(e.g. ICH/GCP, FDA guidelines) • Strong organizational and negotiation skills • Strong attention to detail • Advanced written and oral communication skills • Strong knowledge of English language and grammar • Ability to travel as needed

🏖️ Benefits

• Health insurance • 401(k) plan • Flexible working hours • Paid time off • Professional development opportunities