Start Up Lead APAC

1 hour, 37 minutes ago
Full-time
Senior
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 mitigation, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to gather input for milestone planning and align operational goals for timely start-up delivery.
  • Participate in client meetings to define expectations for communication, reporting, risk management, and site start-up metrics.
  • Partner with functional leaders and site start-up specialists to identify delivery risks and implement mitigation plans.
  • Maintain accurate and current tracking systems and operational data to monitor progress against study, country, and site targets.
  • Coordinate translations for documents required for regulatory submissions.
  • Communicate with feasibility, clinical operations, project management, regulatory, and site contracts teams on project status and deliverables.
  • Act as subject matter expert on site-level critical path items through IMP release, including ethics timelines, reviews, contracts, and budget negotiations.
  • Support country- or site-level start-up activities when needed.
  • Develop country-specific start-up summaries and process flows that identify timelines, risks, and success factors.
  • Lead training sessions, mentor staff, and answer questions on local study start-up regulations, submissions, internal procedures, and SSDL.
  • 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 education, training, and experience.
  • 5 or more years of experience in site start-up, ideally in a Site Start Up Lead or Project Management role within a CRO or pharmaceutical/biotech environment.
  • 2 or more 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 electronic mail.
  • Experience using milestone tracking tools and systems.
  • Fluency in English; for non-English-speaking countries, fluency in the local language of the country where the position is based.
  • Experience with site start-up regulations, submissions, and internal procedures is preferred.

Benefits

  • Opportunity to work for a growing organization focused on groundbreaking cancer therapies and precision medicine.
  • Employee input is valued and encouraged, with opportunities to contribute ideas and drive positive change.
  • Equal Opportunity Employer commitment to fair employment practices.
  • Reasonable accommodation available for applicants with disabilities during the application process.
  • Privacy policy and applicant privacy notice provided for data protection and transparency.

Interested in this position?

Apply directly on the company website

Apply Now

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