Site Start Up Lead APAC

Remotedxb; Dubai; On-site; AED 250,000 - 420,000; Full time

Job summary

Precision for Medicine, a Clinical Research Organization, seeks a seasoned site start-up lead to drive activation readiness and cross-functional coordination across IRB/EC, regulatory, and country-specific processes.

You will partner with stakeholders, mentor staff, and oversee milestone tracking to ensure timely delivery of site start-up activities and risk mitigation in a dynamic CRO environment.

Qualifications

• Bachelor's degree in life sciences, 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

Responsibilities

• Develop activation readiness strategy to guide site start-up processes.
• 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

Leadership

Cross-functional collaboration

Project milestone management

Resource management

Budget coordination

Stakeholder management

English proficiency

Local language proficiency

Education

Bachelor's degree in life sciences or RN or equivalent

Tools

Milestone tracking tools

Computerized information systems

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.