Start Up Lead

Job Description

Precision Medicine Group is seeking a Start Up Lead to manage global site start-up activities. The Start Up Lead will be responsible for the execution of the site start-up strategy and planning, including the management and coordination activities. This role involves acting as a Subject Matter Expert for in-country members, training less-experienced staff, and potentially owning country-specific tools and guidance documents.Responsibilities include:

• Managing the site start-up process and developing an activation readiness strategy.
• Coordinating and presenting critical path planning, including IRB/EC & CA/MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements, and Contract Execution.
• Collaborating with stakeholders to ensure timely delivery of site start-up activities.
• Participating in client meetings to establish expectations for delivery, communication, and risk mitigation.
• Providing oversight to ensure accuracy of tracking and systems.
• Coordinating translations for submission documents.
• Maintaining communication with key functions such as Feasibility, Clinical Operations, and Regulatory.
• Supporting the development of country-specific start-up summaries and training sessions.

Requirements:

• Bachelor's degree in life sciences or related field, or Registered Nurse (RN) or equivalent.
• 5+ years in start-up, ideally with SU Lead or PM experience in a CRO or pharmaceutical/biotech industry.
• 2+ years of experience in project milestone management.
• Demonstrated leadership experience in driving cross-functional activities.
• Excellent communication and organizational skills.
• Experience using computerized information systems.
• Fluency in English.

Role offers:

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