Remote Global Site Start-Up Lead

Precision Medicine Group, LLC.; United States; Remote; USD 92,000 - 137,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

precision medicine group, llc is seeking a Start Up Lead to oversee global site start-up activities, including ICF customization, IRB/EC and MoH submissions, and delivery of IMP release packages. You will act as SME and trainer for in-country staff and may own country-specific tools.

Responsibilities include developing activation readiness strategies, critical path planning, coordinating with stakeholders, risk mitigation, and ensuring timely site activation while maintaining real-time progress

Qualifications

• Bachelor's degree in life sciences or RN or equivalent
• 5+ years in start-up, ideally SU Lead or PM experience in CRO/pharma/biotech
• 2+ years in project milestone management, resources, budgets, and coordinating teams

Responsibilities

• Manage site start-up process with activation readiness strategy
• Coordinate critical path planning for IRB/EC & CA/MoH, ICF customization, risk mitigations
• Collaborate with stakeholders to align milestones and deliverables
• Participate in client meetings to set expectations and report progress
• Partner with functional leaders to mitigate risks and keep timelines
• Ensure tracking systems reflect progress at study, country, and site levels
• Co-ordinate translations for submissions
• Maintain communication with Feasibility, Clinical Operations and Regulatory groups
• Act as SME for country start-up data collection and IMP release data points
• Support country/site start-up activities when needed
• Develop country start-up summaries and process flows
• Facilitate trainings to expand country start-up knowledge
• Mentor staff on regulations, submissions, and procedures
• Interact with clients in proposal and presentations
• Perform other duties as assigned by management

Skills

Demonstrated leadership experience

Excellent communication

Organizational skills

Experience using milestone tracking

Education

Bachelor's degree in life sciences

Registered Nurse (RN)

Tools

Milestone tracking tools

Job description

precision medicine group, llc is seeking a Start Up Lead to oversee global site start-up activities, including ICF customization, IRB/EC and MoH submissions, and delivery of IMP release packages. You will act as SME and trainer for in-country staff and may own country-specific tools.

Responsibilities include developing activation readiness strategies, critical path planning, coordinating with stakeholders, risk mitigation, and ensuring timely site activation while maintaining real-time progress