Senior Assistant Manager / Manager (Study Design Lead)
National Cancer Centre Singapore
- Singapore
- Permanent
- Full-time
- Lead development of study concepts, designs, and protocols for multi-country IITs and translational studies.
- Collaborate with PIs, scientific committees, and industry partners to define objectives, endpoints, and biomarker strategies.
- Ensure designs integrate translational science, statistical methodology, and regulatory requirements.
- Lead manuscripts and abstract development as well as coordinate conference presentation for ESMO Asia and WCLC
- Draft and refine study protocols, synopses, schema, and feasibility questionnaires.
- Conduct feasibility assessments with participating sites, considering country-specific operational challenges.
- Integrate site capabilities, recruitment targets, and vendor requirements into study plans
- Serve as liaison between ATORG/APODDC leadership, site investigators, CROs, and vendors.
- Facilitate consensus meetings, advisory boards, and protocol review committees.
- Engage with pharma, biotech, and funding bodies for study collaboration.
- 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.
- Ensure protocols and trial documents are audit-ready before finalisation.
- 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.
- Ensure compliance with ICH-GCP, local regulations, and consortium SOPs.
- Contribute to grant applications, scientific publications, and conference presentations.
- Support training and mentoring of junior team members in study design and protocol development.
- Undertake other responsibilities as assigned by the PI.
- Master's OR PhD in Life Sciences, Pharmacy, Public Health, or related field; MBBS/MD preferred.
- Formal training or certification in clinical research, medical writing, or biostatistics will be an advantage.
- Minimum 7 years' experience in clinical research, with at least 3 years in study design, medical affairs, or scientific writing/publication roles.
- 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.
- Prior experience working with multi-stakeholder research consortia, academic institutions, or industry collaborators in the Asia-Pacific region.
- Advantageous Skills to Have:
- Scientific Writing & Communication: Excellent ability to translate complex scientific and clinical data into clear, accurate protocols, manuscripts, and presentations.
- Analytical & Problem-Solving: Strong capability to evaluate scientific feasibility, identify risks, and propose practical solutions.
- Stakeholder Engagement: Skilled in managing relationships with investigators, sponsors, vendors, and internal teams across different cultures and geographies.
- Organisational & Project Management: Ability to manage multiple projects concurrently, meet deadlines, and maintain attention to detail.
- Regulatory & Compliance Awareness: Competence in ensuring study design, documentation, and publications comply with international and local regulations, SOPs, and ethical standards.
- Technical proficiency with MS Office, reference management software, and clinical trial management systems (CTMS) is desirable.