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Associate Start up Lead

1 hour, 31 minutes ago
Serbia, Slovakia, Hungary, Poland, Romania
Full-time
Junior
Program 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 through an activation readiness strategy and oversight of delivery.
  • Coordinate critical path planning, including IRB/EC strategy, CA/MoH strategy, ICF customization, risk mitigation, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to gather input for milestone planning and align operational goals for timely 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 plans.
  • Maintain accurate, real-time tracking systems and analyze progress against targets 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 on site-level critical path items, including ethics timelines, reviews, contracts, budget negotiations, and other start-up requirements.
  • Support country- or site-level start-up activities when needed and help develop country start-up summaries, process flows, and training sessions.
  • Mentor staff on local start-up regulations, submissions, internal procedures, and SSDL.
  • Support proposal activities, including slide development and client presentations, and perform other assigned duties.

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 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, 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 or systems.
  • 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, accuracy, time management, and prioritization.
  • Strong computer, presentation, and interpersonal skills.
  • Occasional travel may be required.

Benefits

  • Fully remote work option from Serbia, Romania, Hungary, Slovakia, or Poland.
  • Discretionary annual bonus.
  • Private medical insurance.
  • MultiSport Card.
  • Life insurance.
  • Pension.
  • Home working allowance.
  • Vacation time.
  • Poland salary range of 142,900 PLN to 214,300 PLN gross per annum.

Interested in this position?

Apply directly on the company website

Apply Now

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