Start Up Lead APAC

The role

The Start Up Lead APAC executes site start-up strategy and planning. This role manages document collection, ICF customization, and regulatory submissions while acting as a Subject Matter Expert and trainer.

What you will do

• Manage the site start up process through development of an activation readiness strategy
• Coordinate and present critical path planning including IRB/EC and CA/MoH strategy
• Collaborate with stakeholders to secure input for milestone planning
• Participate in client meetings to establish expectations for delivery and risk mitigation
• Partner with Functional Leaders to identify and mitigate risks to delivery
• Provide oversight to ensure accuracy of tracking and systems
• Coordinate translations for documents required for submissions
• Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management
• Act as SME for site level critical path data points
• Support development and facilitation of training sessions

Required qualifications

• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
• Fluency in English and the local language of the country where position is based
• Experience using milestone tracking tools/systems

Nice to have

• SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry

Before you apply

• Candidates must be legally authorized to work in the country of employment without employer sponsorship

About the company

Precision for Medicine is a Clinical Research Organization. Its integrated offering enables the science of precision medicine by combining clinical trial designs, operational and medical experts, and data analytics solutions.