Job Title: Senior Clinical Trial Manager (Sr. CTM)
Location: Remote (U.S.)
Employment Type: 12-Month Contract-to-Hire
Compensation: $100/hour
About the Company
Our client is a growing pharmaceutical company focused on advancing innovative therapies through late-stage development, with a current emphasis on Phase IIb and Phase III programs in gene therapy. We are seeking a highly skilled and experienced Senior Clinical Trial Manager (Sr. CTM) to join the team on a contract-to-hire basis.
Position Summary
The Senior Clinical Trial Manager will provide leadership and oversight for global clinical trials, ensuring studies are executed with high quality, within budget, and on time. The ideal candidate will bring a strong background in managing Phase IIb/III clinical programs, with significant experience in gene therapy trials and prior hands-on experience as a clinical research coordinator.
Key Responsibilities
- Lead the planning, execution, and management of Phase IIb and Phase III clinical trials.
- Provide operational oversight of CROs, vendors, and study sites to ensure compliance with protocols, timelines, budgets, and regulatory requirements.
- Develop and maintain study timelines, risk management strategies, and operational plans.
- Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Data Management, and other key stakeholders.
- Oversee site selection, study start-up activities, and ongoing monitoring.
- Ensure data integrity, patient safety, and adherence to ICH-GCP and applicable regulatory guidelines.
- Manage trial budgets, including forecasting and tracking expenditures.
- Serve as the primary point of contact for study-related communications with internal and external stakeholders.
- Mentor and provide guidance to junior clinical operations staff.
Qualifications
- Bachelor’s degree in life sciences or a related field (advanced degree preferred).
- Minimum of 7 years of industry experience in clinical research, including at least 3 years in gene therapy trials.
- Direct experience managing global Phase IIb/III clinical trials.
- Previous hands-on experience as a Clinical Research Coordinator required.
- Strong knowledge of ICH-GCP, FDA, and international regulatory requirements.
- Demonstrated ability to manage multiple priorities and adapt to changing project needs.
- Excellent leadership, organizational, and communication skills.
- Ability to work independently in a fully remote environment.
Contract Details
- Duration: 12 months with potential for full-time hire.
- Rate: $100/hour.
- Remote position with potential periodic travel for investigator meetings or site visits
Visit www.viltis.com for more information.
Equal Opportunity Employer
Viltis is an equal opportunity employer and is committed to creating an inclusive environment for all employees. We encourage applicants from diverse backgrounds to apply.