Clinical Affairs Manager - Geylang

• Bachelor’s, Master’s, or Ph.D. in Biomedical Sciences, Clinical Research, Medical Engineering, or a related field.
• 5+ years of experience in clinical research or clinical affairs in medical devices, diagnostics, or health technology.
• Strong understanding of clinical trial design, regulatory pathways, and IRB processes in Singapore and international markets.
• Proven track record in managing clinical studies from concept to completion, including publication of study results.
• Experience with medical writing and working with physicians on research publications is highly desirable.
• Ability to work effectively across different time zones and cultures, managing multiple international sites.
• Strong project management skills with a hands-on and proactive approach.
• Excellent communication and stakeholder management abilities, with the capacity to engage clinicians and researchers globally.
• Scientific and analytical mindset with a keen eye for detail and data integrity.

Responsibilities/Authorities

• Collaborate with Key Opinion Leaders (KOLs), physicians, and researchers to scope clinical opportunities and define study objectives.
• Develop and implement clinical study protocols, ensuring alignment with clinical objectives and business needs.
• Manage the submission process for IRB approvals and compliance with ethical and regulatory requirements across different jurisdictions.
• Coordinate multi-site and international clinical studies, working closely with investigators, study coordinators, and clinical partners.
• Support clinical evaluations ensuring efficient data collection and validation.

• Manage clinical data collection, monitoring, and reporting, ensuring high-quality and scientifically robust outputs.
• Collaborate with statisticians and clinical partners to analyze study results and derive meaningful insights.
• Lead or contribute to the writing and publication of clinical study papers, white papers, and conference abstracts.

• Work closely with R&D, Regulatory, and Commercial teams to align clinical efforts with product development and market entry strategies.
• Identify and engage with new clinical partners and research collaborators worldwide to expand the company’s clinical footprint.

• Stay up to date on regulatory requirements for clinical investigations, ensuring all activities comply with applicable guidelines.
• Work with internal regulatory teams to bridge clinical data with regulatory submissions.
• Ensure proper documentation, monitoring, and auditing of clinical activities.