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Associate Start up Lead

1 hour, 30 minutes ago
Serbia, Slovakia, Hungary, Poland, Romania
Full-time
Mid Level
Project Manager
Project and Program Management
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 159

Description

  • Manage the site start-up process through an activation readiness strategy that supports oversight of delivery.
  • Develop and present critical path planning, including IRB/EC strategy, CA/MoH strategy when assigned, ICF customization, risk mitigations, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to gather input for milestone planning and align operational goals to ensure on-time site activation.
  • Participate in client meetings to define expectations for delivery, communication, risk mitigation, status reporting, and site start-up metrics.
  • Partner with Functional Leaders and Site Start-Up Specialists to identify delivery risks and implement mitigation actions.
  • Oversee tracking systems and ensure accurate, real-time data for progress and timeline analysis at study, country, and site levels.
  • Coordinate translations for documents required for regulatory submissions.
  • Maintain communication with feasibility, clinical operations, project management, regulatory, and site contracts teams on status and deliverables.
  • Act as a subject matter expert on site-level critical path items, including local IRB/EC timelines, reviews, contracts, and budget negotiations.
  • Support country or site-level start-up activities when needed, including training, mentoring, and proposal support.

Requirements

  • Bachelor's degree in life sciences or a related field, or RN, or an equivalent combination of education, training, and experience.
  • 3+ years of experience in start-up, ideally in a Site Start-Up Lead or Project Manager role within CRO, pharmaceutical, or biotech environments.
  • 1+ year of experience in project milestone management, resource management, budgeting, and coordinating 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 software, 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 is 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, accuracy, time management, and prioritization skills.
  • Occasional travel may be required.

Benefits

  • Fully remote work from Serbia, Romania, Hungary, Slovakia, or Poland.
  • Equal Opportunity Employer commitment.
  • Reasonable accommodation support for candidates with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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