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Associate Start up Lead

1 hour, 29 minutes ago
Serbia, Slovakia, Hungary, Poland, Romania
Full-time
Junior
Project Manager
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 106

Description

  • Manage the site start-up process by developing activation readiness strategies and overseeing delivery.
  • Coordinate critical path planning, including IRB/EC strategy, CA/MoH strategy where applicable, ICF customization, risk mitigation, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to gather input, align operational goals, and support timely site activation.
  • Participate in client meetings to establish expectations for delivery, communication, risk mitigation, status reporting, and metrics.
  • Partner with Functional Leaders and Site Start-Up Specialists to identify delivery risks and implement mitigation plans.
  • Ensure tracking systems and study-level metrics are accurate, complete, and maintained in real time.
  • Coordinate translations for documents required for submissions.
  • Maintain communication with feasibility, clinical operations, project management, regulatory, and site contracts teams on project status and deliverables.
  • Act as a subject matter expert on site-level critical path data points, local ethics timelines, contracts, budget negotiations, and other start-up requirements.
  • Support country- and site-level start-up activities when needed, including training, mentoring, and development of country-specific tools and summaries.

Requirements

  • Bachelor’s degree in life sciences or a related field, or RN, or equivalent education, training, and experience.
  • 3+ years of experience in start-up, ideally as a Site Start-Up Lead or Project Manager in a CRO or pharmaceutical/biotech environment.
  • 1+ year of experience managing project milestones, resources, budgets, and team activities.
  • 1+ year of experience presenting to clients.
  • Demonstrated leadership experience driving cross-functional activities.
  • Excellent communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, email, and milestone tracking tools/systems.
  • Fluency in English and, for non-English speaking countries, the local language of the country where the role is based.
  • Advanced degree in life sciences or a related field preferred.
  • Knowledge of Good Clinical Practice, ICH Guidelines, and other applicable regulatory requirements.
  • Ability to work independently in a fast-paced environment with strong attention to detail and accuracy.
  • Excellent time management, prioritization, presentation, and interpersonal skills.
  • Occasional travel may be required.

Benefits

  • Fully remote work option available from Serbia, Romania, Hungary, Slovakia, or Poland.
  • Equal Opportunity Employer status.
  • Reasonable accommodation available for applicants with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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