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Start Up Lead (LATAM)

1 day, 20 hours ago
Mexico
Full-time
Lead
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 132

Description

  • Manage the site start-up process by developing an activation readiness strategy and overseeing delivery.
  • Coordinate critical path planning, including IRB/EC and CA/MoH strategy, ICF customization, risk mitigation, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to align milestone planning and operational goals for on-time site activation.
  • Participate in client meetings to define expectations for delivery, communication, risk mitigation, status reporting, and metrics.
  • Partner with functional leaders and Site Start Up Specialists to identify delivery risks and implement mitigations.
  • Oversee the accuracy and real-time maintenance of tracking systems and progress metrics 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.
  • Serve as subject matter expert for site-level critical path to IMP release data points, including ethics timelines, contract, and budget negotiation requirements.
  • Support country-specific start-up summaries, process flows, training sessions, and mentoring on local regulations and internal procedures.
  • Interact with clients in proposal activities, including slide development and presentation support.
  • Provide direct support for country- or site-level start-up activities when needed.

Requirements

  • Bachelor’s degree in life sciences or a related field, or Registered Nurse qualification, or equivalent education, training, and experience.
  • 5+ years of experience in start-up, ideally in a Start Up Lead or Project Manager role within a CRO or pharmaceutical/biotech environment.
  • 2+ years of experience managing project milestones, resources, budgets, and team activities.
  • Demonstrated leadership experience driving cross-functional activities.
  • Excellent communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Experience using milestone tracking tools or 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 applicable regulatory requirements.
  • Ability to work independently in a fast-paced environment with strong attention to detail, accuracy, and time management.
  • Occasional travel may be required.

Interested in this position?

Apply directly on the company website

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