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Associate Start up Lead

1 hour, 52 minutes ago
Serbia, Slovakia, Hungary, Romania, Poland
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 136

Description

  • Manage the site start-up process through an activation readiness strategy that supports delivery oversight.
  • Coordinate and present critical path planning, including IRB/EC strategy, CA/MoH strategy, ICF customization, risk mitigations, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to gather input for milestone planning and align operational goals for timely site start-up delivery.
  • 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 plans.
  • Ensure tracking systems are accurate and maintained in real time to monitor progress against study, country, and site timelines.
  • 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 and IMP release data points, including local IRB/EC timelines, site contracts, and budget negotiation requirements.
  • Support development of country start-up summaries, process flows, training sessions, and country-specific tools or guidance documents.

Requirements

  • Bachelor's degree in life sciences or a related field, or Registered Nurse (RN), or an equivalent combination of education, training, and experience.
  • 3+ years of experience in start-up, ideally with Site Start-Up Lead or Project Manager experience in a CRO or pharmaceutical/biotech environment.
  • 1+ year of experience in project milestone management, resource management, budget management, and team coordination.
  • 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, electronic mail, and milestone tracking tools/systems.
  • Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based.
  • Advanced degree in life sciences or a related field is preferred.
  • Knowledge of Good Clinical Practice (GCP), 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 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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