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Start Up Lead APAC

2 hours, 8 minutes ago
China, Singapore, South Korea, Taiwan, Australia
Full-time
Senior
Project 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 97

Description

  • Manage the site start-up process by developing an activation readiness strategy and overseeing delivery.
  • Coordinate critical path planning for IRB/EC and 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 set 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.
  • Maintain accurate, real-time tracking systems and provide progress analysis against targets at study, country, and site levels.
  • Coordinate document translations required for regulatory submissions.
  • Work with feasibility, clinical operations, project management, regulatory, and site contracts teams on project status and deliverables.
  • Act as a subject matter expert on country-specific critical path data, including ethics timelines, reviews, contracts, budget negotiations, and other start-up requirements.
  • Support country or site-level start-up activities when needed.
  • Develop country start-up summaries and process flows identifying timelines, risks, and success factors.
  • Design and facilitate training sessions and mentor staff on local regulations, submissions, internal procedures, and site start-up processes.
  • Support client proposal activities, including slide development and client presentations as required.

Requirements

  • Bachelor's degree in life sciences or a related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience.
  • 5+ years of experience in site start-up, ideally in a Site Start-Up Lead or Project Manager role within a CRO, pharmaceutical, or biotech environment.
  • 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; for non-English-speaking countries, fluency in the local language of the country where the position is based.
  • Experience using milestone tracking tools or systems.
  • Experience in global site start-up activities is preferred.
  • Experience supporting regulatory submissions, contracts, and budget negotiation is preferred.

Benefits

  • Opportunity to work in a growing organization focused on groundbreaking cancer therapies and other therapeutic areas.
  • Employee ideas are valued and encouraged, with opportunities to contribute to positive change.
  • Equal opportunity employer status.
  • Reasonable accommodation support for applicants with disabilities during the application process.
  • Job location flexibility across Australia, Singapore, South Korea, Taiwan, or China.

Interested in this position?

Apply directly on the company website

Apply Now

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