Site Start Up Lead APAC

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

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

Requirements

• Bachelor's degree in life sciences, Registered Nurse (RN), or equivalent experience
• 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

About the Company

Precision for Medicine is a Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.