Global Site Start-Up Lead

Precision for Medicine

Pittsburgh (Allegheny County)

On-site

USD 92,000 - 137,000

Full time

4 days ago
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Benefits offered by this job

Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave andvacati

Job summary

Precision for Medicine is seeking an experienced Start-up Lead to oversee site start-up activities in the United States. You will drive activation readiness, coordinate IRB/EC, CA/MoH submissions, and deliver quality IMP release packages while guiding country-specific processes.

You will partner with functional leaders and site start-up staff to manage critical path planning, risk mitigations, budgeting, and milestone tracking, ensuring timely site initiation and activation across studies.

Qualifications

  • Bachelor's degree or RN or equivalent combination of education, training, and experience.
  • 5+ years in startup, ideally with SU Lead or PM experience in CRO/pharma.
  • 2+ years in milestone management, managing resources, budgets and coordinating team activities.

Responsibilities

  • Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
  • Coordinate, develop and present critical path planning including IRB/EC and CA/MoH strategy, ICF customization, risk mitigations, IMP release requirements and contract execution.
  • Collaborate with stakeholders to secure input for milestone planning and alignment of operational goals to ensure timely delivery of site start up activities.
  • Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
  • Partner with functional leaders and site start up specialists to identify risks to delivery and develop mitigations to remove risks to timelines.
  • Provide oversight to ensure tracking and systems are maintained in real time to analyze progress metrics against targets/timelines.

Skills

Leadership experience
Excellent communication
Organizational skills
English proficiency

Education

Bachelor's degree in life sciences or related field
Advanced degree in life sciences (preferred)

Tools

Milestone tracking tools

Job description

Precision for Medicine is seeking an experienced Start-up Lead to oversee site start-up activities in the United States. You will drive activation readiness, coordinate IRB/EC, CA/MoH submissions, and deliver quality IMP release packages while guiding country-specific processes.

You will partner with functional leaders and site start-up staff to manage critical path planning, risk mitigations, budgeting, and milestone tracking, ensuring timely site initiation and activation across studies.

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