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Associate Start up Lead

1 hour, 55 minutes ago
Serbia, Slovakia, Hungary, Poland, Romania
Full-time
Mid Level
Program 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 119

Description

  • Manage the site start-up process by developing an activation readiness strategy and overseeing delivery.
  • Coordinate critical path planning, including IRB/EC strategy, CA/MoH strategy when assigned, ICF customization, risk mitigation, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to secure input for milestone planning and align operational goals for on-time 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 execute mitigation plans.
  • Oversee tracking systems to ensure data accuracy and completeness for progress analysis at study, country, and site levels.
  • 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 for site-level critical path, IMP release data points, submissions, and local start-up requirements.
  • Support country- and site-level start-up activities when needed, including training, mentoring, and development of country-specific tools and summaries.
  • Support proposal activities, including slide development and client presentations as required.

Requirements

  • Bachelor's degree in life sciences or a related field, or RN, or equivalent combination of education, training, and experience.
  • 3+ years of experience in start-up, ideally as a SU Lead or PM 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, 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/ICH Guidelines and other applicable regulatory requirements.
  • Ability to follow task-specific procedures, maintain attention to detail, and ensure accuracy of information.
  • Ability to work independently in a fast-paced environment with urgency.
  • Excellent time management, prioritization, presentation, interpersonal, and computer skills.
  • Occasional travel may be required.

Benefits

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

Interested in this position?

Apply directly on the company website

Apply Now

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