clinical operations associate/director in Singapore

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job details

posted
location
singapore
specialism
life science
job type
permanent
reference number
90M0343320_1524824720
contact
jin quan jonathan soh, randstad
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job description

Overview of the role

This individual will be accountable for the oversight of clinical and operational aspects of the company’s clinical trials. The incumbent will be responsible for the strategy and long-term direction of Clinical Operations. The Clinical Operations Director will work closely with multi-disciplinary departments and will require a solid understanding of the clinical trial lifecycle management such as study startup, feasibility, patient recruitment, project management, trial quality and data management.

Job Description:

  • Direct clinical operations activities including developing the clinical research strategy, investigator and site selection, interim and final analyses, qualification of CROs and evaluating their performance.
  • Develop and monitor Key Performance Indicators (KPIs) to track the progress of the ongoing clinical trials
  • Ensure appropriate monitoring oversight plans are in place, and reflect adequate adherence to local regulatory authorities, GCP and SOPs
  • Ensure alignment of activities/decisions affecting all trials within the clinical development pipeline
  • Develop and maintain departmental standard operating procedures (SOPs) in collaboration with Clinical Development, Regulatory Affairs and Quality Assurance
  • Oversight to ensure timely and appropriate response and resolution to study management issues
  • Prepare communication and status reports to provide updates/information to senior management
  • Actively participate in strategic planning activities including department budgeting and resource management
  • Manage strategic partners, supervise and mentor direct and indirect reports to assure performance and progress on assigned projects as appropriate

Requirements

  • Strong working knowledge and interpretation of FDA and ICH – GCP regulations and guidelines
  • Broad and direct experience with regulatory authority inspections, including FDA inspections with experience from Sponsor’s company

Qualification(s)

  • Bachelor’s Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study
  • More than 10 years of experience working in clinical trial operations and project management and at least 3 years from Sponsor’s company (pharma companies)
  • Extensive experience in oncology drug development, experience in immuno-oncology an added advantage
  • Demonstrate proficiency in FDA and ICH rules, regulations and guidelines governing conduct of clinical studies, clinical protocols, investigator brochures and other materials