Clinical Research Study Design Lead

4 days ago

Singapore beBeeStudyDesign Full time

Job Overview

We are seeking a highly skilled Clinical Research Study Design Lead to join our team. As a key member of our research group, you will be responsible for leading the scientific and operational design of multi-country oncology research programs.

Main Responsibilities

  • Scientific Communication & Publication: Develop study concepts, designs, and protocols for multi-country IITs and translational studies, collaborate with PIs, scientific committees, and industry partners, and ensure designs integrate translational science, statistical methodology, and regulatory requirements.
  • Protocol & Feasibility Development: Draft and refine study protocols, synopses, schema, and feasibility questionnaires, conduct feasibility assessments with participating sites, and integrate site capabilities, recruitment targets, and vendor requirements into study plans.
  • Stakeholder Engagement: Serve as liaison between leadership, site investigators, CROs, and vendors, facilitate consensus meetings, advisory boards, and protocol review committees, and engage with pharma, biotech, and funding bodies for study collaboration.
  • Quality Assurance (QA) Integration: Embed quality-by-design principles into protocol and operational workflows, review study-specific operational, safety monitoring, and data management plans for compliance with ICH-GCP and consortium SOPs, and ensure protocols and trial documents are audit-ready before finalisation.
  • Operational & Quality Oversight: Collaborate with Clinical Operations to ensure designs are executable within timelines and budgets, support the development of safety monitoring, QA frameworks, and data management plans, and ensure compliance with ICH-GCP, local regulations, and consortium SOPs.

Required Skills and Qualifications

  • Master's or PhD in Life Sciences: Formal training or certification in clinical research, medical writing, or biostatistics will be an advantage, minimum 7 years' experience in clinical research, at least 3 years in study design, medical affairs, or scientific writing/publication roles.
  • Proven Track Record: Proven track record in designing and implementing multi-country investigator-initiated trials or equivalent academic-led research, experience integrating QA/quality-by-design principles into clinical study planning, demonstrated success in developing and publishing peer-reviewed manuscripts and abstracts for scientific meetings, and prior experience working with multi-stakeholder research consortia, academic institutions, or industry collaborators in the Asia-Pacific region.

Benefits

This role offers opportunities for career growth and professional development in a dynamic and collaborative environment.

Please submit your application through our online portal.

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