ICON plc
ICON plc
ICON plc is a global contract research organisation serving the healthcare and pharmaceutical industries. Its work spans clinical, consulting, and commercial services that support drug development from early research through post-marketing activities. The company provides solutions including decentralised clinical trials, cardiac safety, early clinical laboratories, medical imaging, regulatory intelligence, and real-world evidence. ICON plc also brings therapeutic expertise to areas such as cardiovascular disease, oncology, internal medicine, cell and gene therapies, and biosimilars, combining data analysis with patient-focused approaches to help advance clinical programmes.

Study Start-Up Manager, Malaysia (Remote)

Lead clinical trial site start-up and activation for ICON plc in Malaysia. Manage study start-up teams, regulatory submissions, timelines, budgets, and process improvements.

Description

  • Oversee daily site start-up and activation work.
  • Coordinate the full study start-up cycle, from site selection and feasibility through regulatory submissions and activation.
  • Guide and mentor a team of study start-up professionals.
  • Work with sponsors, clinical operations, and regulatory teams to meet local and global requirements and timelines.
  • Track start-up performance, schedules, and budgets.
  • Assess start-up risks and put mitigation plans in place.
  • Improve study start-up processes to increase efficiency.

Requirements

  • Hold a bachelor’s degree in a relevant science or healthcare field.
  • Bring substantial experience in clinical trial start-up, with strong knowledge of global regulatory requirements and clinical operations.
  • Have a track record of leading and mentoring teams in fast-paced, deadline-focused settings.
  • Demonstrate strong organization and project management skills, including the ability to oversee multiple studies and competing priorities.
  • Communicate effectively and manage relationships with sponsors and internal stakeholders.
  • Have experience improving processes and applying best practices to study start-up work.
  • Be willing to travel as needed, approximately 25%.
  • Have legal authorization to work in Malaysia.

Benefits

  • Competitive base pay with performance-related incentives.
  • Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
  • Retirement and pension plans.
  • Life assurance and disability coverage.
  • Employee assistance programs and wellbeing resources.
  • Structured training and career pathways for learning and development.

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