Start Up Lead

The role

The Start Up Lead executes global site start-up strategy and planning. This includes managing document collection, ICF customization, and regulatory submissions.

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 and Site Start up Specialists to identify and mitigate risks
• Provide oversight to ensure accuracy and completeness of tracking and systems
• Coordinate translations for documents required for submissions
• Maintain communication with key functions on project specific status and deliverables
• Act as SME for collection and maintenance of site level critical path data
• Support development and facilitation of training sessions

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 for non-English speaking countries the local language of country where position based
• Experience using milestone tracking tools/systems

Nice to have

• Advanced degree in life sciences or related field

Benefits

• discretionary annual bonus
• health insurance
• retirement savings benefits
• life insurance
• disability benefits
• parental leave
• paid time off for sick leave and vacation

Before you apply

• Candidates must be legally authorized to work in the country of employment without employer sponsorship

About the company

Precision Medicine Group is an Equal Opportunity Employer.