MedTech Catapult is a national initiative for accelerating the development of high-value MedTech projects. The product development unit is responsible for supporting the medical device development cycle with project management, quality, regulatory and clinical affairs capabilities.
The Clinical Affairs Senior Manager will report to the Deputy Director, Product Development.
Job Responsibilities
- Lead the planning, execution, and management of clinical studies to ensure demonstration of the safety, performance, and benefits of a medical device and adherence to regulatory requirements and industry standards.
- Assist with the identification of experts to co-create clinical testing, validation and adoption strategies across local and international healthcare institutions.
- Support the collection of clinical insights, identification of the intended use and translation into product development requirement specifications.
- Foster positive relationships with healthcare professionals, clinical partners, and key opinion leaders, to ensure smooth collaboration with cross-functional teams to develop and refine clinical study protocols, ensuring alignment with product objectives and regulatory expectations and compliance with legal and ethical standards.
- Establish and maintain relationships with clinical sites, investigators, and key stakeholders, overseeing site selection, initiation, monitoring, and close-out activities.
- Establish and develop the implementation of medical technology guidance adoption strategies, working with a broad range of stakeholders including front-line clinicians and other healthcare and operations staff, suppliers of products and other industry partners.
- Work with Quality team to ensure compliance with regulatory submissions, approvals and reporting, keeping abreast of evolving regulatory landscapes to guide clinical strategy.
- Work closely with key agencies and stakeholders to seek informed opinion and evidence that will strengthen the design and execution of the clinical validation and adoption process.
- Assist with the identification and management of project risks and develop practical and rational proposals to address issues.
- Compile and evaluate evidence in clinical evaluation reports and conduct after-action review.
- Balance the workload of multiple projects with different approaches and at different stages.
Requirements
- PhD or Degree in relevant field, preferably in medicine, biology, pharmacy, or chemistry degree
- At least 3 years of relevant experience
- Knowledge of clinical governance, clinical study research and ethics compliance, confidentiality issues, research methods and guidelines, data protection, intellectual property rights etc
- Demonstrated ability to translate scientific, clinical and safety research studies in an effective credible manner
- Ability to maintain a command of a large amount of scientific information across multiple products and make a decision regarding clinical evidence of importance.
- Demonstrate excellent project management skills
- Excellent written and oral communication skills
The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.
