Start Up Lead APAC

1 month, 1 week ago
Lead
Project and Program Management
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

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 mitigations, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to gather input for milestone planning and align operational goals for on-time activation.
  • Participate in client meetings to define expectations for delivery, communication, risk management, status reporting, and metrics.
  • Partner with functional leaders and site start-up specialists to identify delivery risks and execute mitigation plans.
  • Ensure tracking systems and study/country/site-level progress metrics are accurate, complete, and maintained in real time.
  • 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 subject matter expert for site-level critical path and IMP release data points, including ethics timelines, site contracts, and budget negotiation requirements.
  • Support country-specific summaries, process flows, training sessions, and mentoring on local start-up regulations and submissions.

Requirements

  • Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent 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 and, for non-English speaking countries, the local language of the country where the position is based.
  • Experience using milestone tracking tools or systems.
  • Experience with site start-up regulations, submissions, internal procedures, and SSDL is preferred.
  • Location based in Australia, Singapore, South Korea, Taiwan, or China.

Interested in this position?

Apply directly on the company website

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