Start Up Lead - Remote

Overview

The Start Up (SU) 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, develop and present critical path planning including IRB/EC & CA/ MoH Strategy.
• Collaborate with stakeholders to secure input for milestone planning.
• Participate in client meetings to establish client expectations.
• Partner with Functional Leaders to identify risks to delivery.
• Provide oversight to ensure accuracy and completeness of tracking systems.
• Coordinate translations for submission documents.
• Maintain communication with key functions on project status.
• Act as SME for collection and maintenance of site level critical path.
• Support development of country specific start-up summaries.

Requirements

• Bachelor's degree in life sciences or related field, or equivalent experience.
• 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 driving cross-functional activities.
• Excellent communication and organizational skills.
• Fluency in English and local language where applicable.

Benefits

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