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Start Up Lead APAC

23 hours, 21 minutes ago
China, Singapore, South Korea, Taiwan, Australia
Full-time
Senior
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 11

Description

  • Manage the site start-up process by developing and executing an activation readiness strategy to ensure on-time site activation.
  • Coordinate, develop and present critical path planning including IRB/EC & CA/MoH strategy, ICF customization, risk mitigations, IMP release requirements, and contract execution.
  • Collaborate with stakeholders and participate in client meetings to align milestone planning, set delivery expectations, communicate status, and define risk mitigation strategies and metrics.
  • Partner with Functional Leaders and Site Start Up Specialists to proactively identify risks to delivery and develop and implement mitigation plans to protect timelines.
  • Provide oversight and maintain accuracy of tracking systems and real-time progress metrics at study, country, and site levels.
  • Coordinate translations for submission documents and maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts teams on country start-up status and deliverables.
  • Act as subject-matter expert for site-level critical path data (local IRB/EC timelines, required reviews, site contracts/budget negotiations, IMP release data points) and provide direct country/site-level support when needed.
  • Develop country-specific start-up summaries and process flows identifying timelines, risks, and success factors.
  • Develop and deliver training sessions, mentor staff on local study start-up regulations, submissions, internal procedures, and act as an SME for queries.
  • Support proposal activities and client-facing materials, including slide development and presentations as required.

Requirements

  • Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience.
  • 5+ years’ experience in site start-up with SU Lead or project management experience in a CRO, pharmaceutical or biotech environment (or equivalent relevant experience).
  • 2+ years’ experience in project milestone management, resource and budget management, and coordinating team activities.
  • Demonstrated leadership driving cross-functional activities and mentoring less-experienced staff.
  • Expertise in global site start-up activities including IRB/EC & CA/MoH submissions, ICF customization, and delivery of quality IMP release packages.
  • Experience using milestone tracking tools/systems and computerized information systems (spreadsheets, word processing, email).
  • Excellent communication and organizational skills.
  • Fluency in English and, for roles based in non-English-speaking countries, fluency in the local language of the country where the position is based.
  • Willingness/ability to be based in APAC locations (Australia, Singapore, South Korea, Taiwan, China) and interact with clients and cross-functional teams.

Benefits

  • Opportunity to work on groundbreaking cancer and rare disease clinical research programs.
  • Company culture that values employee contributions, with ideas encouraged and nurtured to impact positive change.
  • Opportunities for mentoring, training and professional development through SME and leadership responsibilities.
  • Collaborative, cross-functional and client-facing role with international exposure across APAC.
  • Equal Opportunity Employer with reasonable accommodations available for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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