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 groups.
• Act as SME for site level critical path data points.
• Support development and facilitation of training sessions and mentor staff.

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, relevant experience and/or demonstrated competencies.
• 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

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.