Clinical Affairs Manager

Private Advertiser; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

An established industry player in health technology is seeking a Clinical Research Manager to lead innovative clinical studies. This role involves collaborating with key opinion leaders and managing multi-site clinical trials, ensuring compliance with regulatory standards. The ideal candidate will possess a strong background in clinical research, excellent project management skills, and the ability to communicate effectively across diverse teams. Join a dynamic environment where your contributions will drive advancements in medical devices and diagnostics, making a significant impact on patient care and clinical outcomes.

Qualifications

• 5+ years of experience in clinical research or clinical affairs.
• Strong understanding of clinical trial design and regulatory pathways.

Responsibilities

• Collaborate with KOLs and researchers to define study objectives.
• Manage multi-site and international clinical studies effectively.
• Lead the writing and publication of clinical study papers.

Skills

Clinical Research

Project Management

Regulatory Compliance

Data Analysis

Medical Writing

Stakeholder Management

Communication Skills

Cross-Cultural Collaboration

Education

Bachelor’s in Biomedical Sciences

Master’s in Clinical Research

Ph.D. in Medical Engineering

Job description

Competency Requirements

• 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

Clinical Study Strategy & Execution

• 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.

Data Analysis & Scientific Publications

• 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.

Cross-functional Collaboration

• 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.

Regulatory & Compliance Oversight

• 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.