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Start Up Lead (LATAM)

3 hours, 58 minutes ago
Mexico
Senior
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 4

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 mitigations, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to align milestone planning and operational goals for on-time activation.
  • Participate in client meetings to define 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 mitigations.
  • Oversee tracking systems to ensure accurate, real-time maintenance of study, country, and site progress metrics.
  • Coordinate translations for documents required for regulatory 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 data, local ethics timelines, contract and budget negotiation requirements, and other start-up requirements.
  • Support country-specific start-up summaries, process flows, and training sessions; mentor staff on local regulations, submissions, internal procedures, and SSDL.
  • Interact with clients in proposal activities, including slide development and presentations, as needed.
  • Perform other duties as assigned by management.

Requirements

  • Bachelor’s degree in life sciences or a related field, Registered Nurse (RN), or equivalent combination of 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, or equivalent relevant experience.
  • 2+ years of experience in project milestone management, resource management, budget management, and team coordination.
  • 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 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 urgency and strong attention to detail.
  • Strong time management, prioritization, presentation, interpersonal, and persuasive communication skills.
  • Occasional travel may be required.

Interested in this position?

Apply directly on the company website

Apply Now

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