Senior Clinical Trial Manager/Clinical Trial Manager - Radiopharmaceutical

Job Description

Precision Medicine Group is seeking a Senior Clinical Trial Manager to lead the operational aspects of clinical studies, ensuring they adhere to protocols, SOPs, ICH-GCP guidelines, and regulatory requirements. This role involves serving as the primary clinical point of contact with the client and collaborating with the Project Manager on budget management. The Senior Clinical Trial Manager will develop study-related clinical documents, identify training needs for CRAs and vendors, and drive the site feasibility process. They will also develop recruitment strategies, maintain communication with investigators, and lead internal clinical team meetings. Responsibilities:

• Developing study related clinical documents
• Identifying training needs for CRAs and third-party vendors
• Generating potential site list and drive site feasibility process
• Developing country recruitment/retention strategy
• Leading internal clinical team meetings
• Overseeing submissions to Competent Authorities and IRB/Ethics Committees
• Managing eTMF implementation

Requirements:

• Bachelor’s degree in science or health-related field (advanced degree preferred)
• Minimum of 7 years of clinical research experience with significant clinical monitoring experience
• Experience with Microsoft Office Products
• Excellent communication and organizational skills
• Ability to travel domestically and internationally
• Mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance

The role offers:

• A remote work environment within the United States
• Opportunity to collaborate with cross-functional teams
• Discretionary annual bonus
• Health insurance, retirement savings benefits, life insurance and disability benefits
• Parental leave, and paid time off for sick leave and vacation