Start Up Lead - Remote

Overview

The Start Up Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

In Short

• 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.
• Collaborate with stakeholders to ensure timely delivery of site start up activities.
• Participate in client meetings to establish expectations and metrics.
• Identify risks to delivery and develop mitigations.
• Ensure accuracy of tracking systems maintained in real time.
• Responsible for coordinating translations for submissions.
• Maintain communication with key functions on project status.
• Act as SME for site level critical path data points.
• Support development of training sessions to expand Country Start-up knowledge.

Requirements

• Bachelor's degree in life sciences or related field, or equivalent.
• 5 years or more in start up, ideally with SU Lead or PM experience.
• 2 years or more experience in project milestone management.
• Demonstrated leadership experience in cross-functional activities.
• Excellent communication and organizational skills.
• Fluency in English and local language if applicable.
• Experience using computerized information systems.
• Ability to follow task-specific procedures and be detail-oriented.
• Ability to work independently in a fast-paced environment.
• Occasional travel may be required.

Benefits

• Discretionary annual bonus.
• Health insurance.
• Retirement savings benefits.
• Life insurance and disability benefits.
• Parental leave and paid time off for sick leave and vacation.