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Associate Start up Lead

1 hour, 47 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 146

Description

  • Manage the site start-up process by developing an activation readiness strategy and overseeing site start-up delivery.
  • Coordinate 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 support timely site activation.
  • Participate in client meetings to define delivery expectations, communication plans, risk mitigation approaches, status reporting, and site start-up metrics.
  • Partner with Functional Leaders and Site Start-up Specialists to identify delivery risks and implement mitigation actions.
  • Ensure tracking systems are accurate, complete, and maintained in real time to monitor progress against targets at study, country, and site levels.
  • Coordinate translations for documents needed for submissions.
  • Maintain communication with feasibility, clinical operations, project management, regulatory, and site contracts teams on project status and deliverables.
  • Serve as a subject matter expert on site-level critical path items, including IRB/EC timelines, site contracts, budget negotiations, and other activation requirements.
  • Support country- and site-level start-up activities when needed, including training development, mentoring, and proposal support.

Requirements

  • Bachelor's degree in life sciences or a related field, Registered Nurse (RN) qualification, 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 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, and email.
  • Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based.
  • Experience using milestone tracking tools/systems.
  • Advanced degree in life sciences or a related field (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 and accuracy.
  • Excellent time management, prioritization, computer, presentation, and interpersonal skills.
  • Occasional travel may be required.

Benefits

  • Fully remote work option from Serbia, Romania, Hungary, Slovakia, or Poland.
  • Equal Opportunity Employer status.
  • Reasonable accommodation available for candidates with disabilities during the application process.
  • Privacy policy coverage for applicant data, including a CA privacy notice for California applicants.

Interested in this position?

Apply directly on the company website

Apply Now

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