Senior Remote Clinical Trials Lead

Precision Medicine Group, LLC.; United States; Remote; USD 111,000 - 201,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement benefits

Life insurance

Parental leave

Disability benefits

Paid time off

Job summary

Precision Medicine Group, LLC is seeking a highly experienced Clinical Trial Lead to plan, conduct and oversee the operational aspects of clinical studies in accordance with protocol, SOPs, ICH-GCP and applicable regulatory requirements worldwide. The role requires collaboration with project managers, sites and vendors to ensure enrollment targets, timely delivery, and data quality.

A bachelor’s degree in science or health-related field and 7+ years of clinical research experience are essential,

Qualifications

• Bachelor’s degree in science or health-related field; advanced degree preferred
• 7+ years of clinical research experience with significant monitoring experience
• Experience with ICH-GCP and regulatory guidelines

Responsibilities

• Primary clinical point of contact with the client
• Collaborate with PM on monthly invoicing and budget variance management
• Develop study documents (clinical plans, ICF templates, CRF guidelines, study trackers)
• Identify training needs for CRAs and vendors and present at Investigator Meetings
• Lead site feasibility processes and recruitment strategies
• Develop country recruitment/retention strategies
• Oversee regulatory submissions and IP release packages
• Manage eTMF implementation and CAPA processes
• Support sites and CRAs for inspections and audits
• Ensure data quality with CRAs and data management during cleaning timelines

Skills

Excellent communication

Leadership

Cross-functional collaboration

Budgeting & invoicing

Risk management

Time management

Attention to detail

Client liaison

Analytical thinking

Education

Bachelor’s degree in science or health-related field

Advanced degree preferred

Tools

Microsoft Office

Job description

Precision Medicine Group, LLC is seeking a highly experienced Clinical Trial Lead to plan, conduct and oversee the operational aspects of clinical studies in accordance with protocol, SOPs, ICH-GCP and applicable regulatory requirements worldwide. The role requires collaboration with project managers, sites and vendors to ensure enrollment targets, timely delivery, and data quality.

A bachelor’s degree in science or health-related field and 7+ years of clinical research experience are essential,