Start Up Lead APAC

About the Role

As a key member of the Precision for Medicine team, the Start Up Lead APAC will play a critical role in ensuring the timely and efficient delivery of site start-up activities. This will involve working closely with stakeholders, including site investigators, ethics committees, and regulatory authorities, to secure approvals and ensure compliance with regulatory requirements.

The Start Up Lead APAC will be based in Singapore and will report to the regional director of clinical operations. They will be responsible for managing a team of site start-up specialists and will be expected to provide guidance and support to less experienced team members.

What You Will Do

• Manage the site start-up process, including the development of an activation readiness strategy and the coordination of core document collection and approval
• Develop and present critical path planning, including IRB/EC & CA/MoH strategy, ICF customization, risk mitigations, IMP release requirements, and contract execution
• Collaborate and communicate with stakeholders to secure input for milestone planning and alignment of operational goals
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start-up
• Partner closely with functional leaders and site start-up specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real-time to allow analysis of progress metrics against targets/timelines at study, country, and site levels
• Coordinate translations for documents required for submissions
• Maintain communication with other key functions participating in country start-up, including feasibility, clinical operations, project management, regulatory, and site contracts management group on project-specific status and deliverables
• Act as SME for collection and maintenance of site-level critical path to IMP release data points
• Support development of country-specific country start-up summary and process flow identifying timelines, risks, and success factors
• Support development and facilitation of training sessions to expand country start-up knowledge and act as Subject Matter Expert for queries

What We Are Looking For

• Bachelor's degree in life sciences or a related field, or a registered nurse (RN) or equivalent combination of education, training, and experience
• At least 5 years of experience in start-up, ideally with SU lead or PM experience in either a CRO or pharmaceutical/biotech industry
• Strong knowledge of Excel and data analytics
• Experience with site start-up activities, including core document collection and approval, ICF customization, and IRB/EC submissions
• Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams
• Ability to manage multiple projects simultaneously and prioritize tasks effectively
• Strong attention to detail and ability to maintain accurate and complete records
• Ability to travel up to 20% of the time

Nice to Have

• Experience with clinical trial management systems and electronic data capture systems
• Knowledge of APAC regulatory requirements and guidelines
• Experience with project management tools, such as Asana or Trello
• Certification in clinical research or a related field

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work with a leading clinical research organization
• Collaborative and dynamic work environment
• Professional development and training opportunities
• Flexible working hours and remote work options
• Access to the latest technology and tools
• Recognition and reward for outstanding performance
• Comprehensive health and wellness programs
• Generous paid time off and holiday entitlement

• Familiarize yourself with the APAC regulatory environment and guidelines to demonstrate your knowledge and expertise in site start-up activities
• Highlight your experience with Excel and data analytics, and be prepared to provide examples of how you have used these tools in previous roles
• Emphasize your ability to work effectively in a team environment and collaborate with cross-functional stakeholders
• Be prepared to discuss your experience with project management tools and systems, and how you have used these to manage multiple projects simultaneously
• Research Precision for Medicine and the clinical trials industry to demonstrate your knowledge and interest in the company and the role
• Practice your presentation skills, as you will be required to present critical path planning and other information to stakeholders
• Be prepared to discuss your experience with risk mitigation and problem-solving, and provide examples of how you have handled challenging situations in previous roles