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. The Manager of Clinical Trials will be an integral part of the organization and play a key role in maintaining high standards and consistency across all sites. Prior experience as a Clinical Research Coordinator (CRC) is required. The role in onsite in Montgomery County, MD and requires some travel, particularly during the initiation and conclusion phases of trials.

Key Responsibilities

• Setting up and overseeing clinical trials across multiple locations.
• Training and guiding staff while fostering operational excellence.
• Translate study protocols into actionable processes and coach clinical trial staff to ensure success.
• Ensure adherence to all relevant regulatory guidelines (e.g., ICH GCP) throughout the trial.
• 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.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or a related field. Preferred, not required.
• Minimum 2 years of leadership experience in clinical trial operations.
• Fluency in reading oncology protocols, highly preferred.
• Strong understanding of FDA, GCP, ICH, and clinical trial quality management standards.
• Has worked in a complex working environment, like ICU or RPO-CTO, highly preferred.
• 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.