Manager of Clinical Trials
Are you passionate about revolutionizing clinical trial operations? Join a dynamic team dedicated to advancing precision medicine and improving access to groundbreaking radiopharmaceutical therapies.
About the Role
As the Manager of Clinical Trials, you will play a pivotal role in setting up and overseeing clinical trials across multiple locations. This hands-on position involves training and guiding staff, ensuring compliance with regulatory requirements, and fostering operational excellence. The role requires some travel, particularly during the initiation and conclusion phases of trials.
Key Responsibilities
- Lead the implementation and management of Clinical Trial Management Systems (CTMS).
- Oversee quality management systems at central, site, and study levels.
- Manage regulatory compliance, including deviation management and communication with IRBs and sponsors.
- Develop training systems, SOPs, and audit-readiness programs aligned with FDA and BIMO standards.
- Collaborate with contract resource organizations (CROs), vendors, sponsors, and healthcare providers.
- Translate study protocols into actionable processes and coach clinical trial staff to ensure success.
Qualifications
- Bachelor’s degree in life sciences, healthcare, or a related field.
- Minimum 5 years of leadership experience in clinical trial regulatory management.
- Strong understanding of FDA, GCP, ICH, and clinical trial quality management standards.
- Proven experience with CAPA, root cause analysis, and FDA 483 handling.
- Excellent project management and organizational skills.
- Strong communication skills and a proactive, adaptable mindset.
- Ability to travel and flexibility to work outside standard business hours when needed.
