APAC Site Start-Up Lead — CRO Operations & Strategy

Precision for Medicine; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Precision for Medicine is seeking an experienced Site Start-Up Lead to drive activation readiness, coordinate IRB/EC approvals, ICF customization, and risk mitigation across studies in the United States.

You will collaborate with functional leaders, manage milestones and budgets, and mentor staff on local start-up regulations and internal procedures to ensure timely delivery and accurate tracking of activities.

Qualifications

• Bachelor's degree in life sciences (or RN) required.
• 5+ years in start up, ideally with SU Lead or PM experience in CRO or pharma/biotech.
• 2+ years in project milestone management, resource management, and budget coordination.
• Demonstrated leadership in driving cross-functional activities.
• Proficiency in computerized information systems and milestone tracking tools.
• Fluency in English and the local language of the country where based.

Responsibilities

• Manage the site start up process through development of an activation readiness strategy
• Coordinate and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, and Risk Mitigations
• Collaborate with stakeholders to ensure timely delivery of site start up activities
• Participate in client meetings to establish expectations for delivery, communication, and risk mitigation
• Partner with Functional Leaders to identify and mitigate risks to timelines
• Provide oversight to ensure accuracy and completeness of tracking systems
• Coordinate translations for required submission documents
• Maintain communication with Feasibility, Clinical Operations, Project Management, and Regulatory teams
• Act as Subject Matter Expert for site level critical path data points
• Support development of country specific start-up summary and process flows
• Mentor staff on local study start-up regulations and internal procedures

Skills

Cross-functional leadership

Milestone tracking tools

Leadership

Fluent English

Milestone management

Resource management

Budget coordination

Education

Bachelor's degree in life sciences

Job description

Precision for Medicine is seeking an experienced Site Start-Up Lead to drive activation readiness, coordinate IRB/EC approvals, ICF customization, and risk mitigation across studies in the United States.

You will collaborate with functional leaders, manage milestones and budgets, and mentor staff on local start-up regulations and internal procedures to ensure timely delivery and accurate tracking of activities.