Clinical Manager

at  GYROGEAR PTE LTD

Award-winning medical device startup (GyroGear.co ) has a single opening for a Clinical Manager at our Singapore office . We are developing intelligent wearable devices to stabilise hand tremors for 200 million people globally.
The candidate must be able to effectively understand and address the needs and problems, and to do so with a small and focused team operating in a driven startup environment. The ultimate objective is to deliver a commercially successful GyroGlove within the coming year.

For more information about GyroGear and the GyroGlove please visit www.gyrogear.co .

• BBC One Show Intro (Apr 2018) - https://vimeo.com/269487349/fc7ef6c621
• User evaluation with patient (Mar 2019) - https://vimeo.com/330355695/30e5070965
• Reuters AI Summit cover (Jun 2019) - https://vimeo.com/342811081

QUALIFICATIONS:

• Bachelor’s degree in Nursing, Life Sciences, or a related field; advanced degree (e.g., Master’s, PhD, MD) preferred.
• 5+ years of experience in clinical trial management, preferably in the MedTech or biotech industry.
• Strong knowledge of GCP, FDA regulations, ISO standards, and other relevant regulatory frameworks.
• Proven experience in leading cross-functional teams and managing clinical studies from initiation to completion.
• Excellent communication, organizational, and leadership skills.
• Ability to work in a fast-paced, dynamic environment with a startup mentality.
• Proficiency in clinical trial management systems (CTMS) and other relevant software tools.

We are looking for a Clinical Manager whose responsibilities include, but are not limited to:

• Clinical Trial Management:
• Lead the planning, design, and execution of clinical studies and trials to support product development and regulatory submissions.
• Oversee site selection, patient recruitment, and data collection to ensure the success of clinical trials.
• Collaborate with principal investigators, site coordinators, and CROs to manage clinical trial operations.
• Monitor study progress, including timelines, budgets, and milestones, and report to senior management.
• Regulatory Compliance:
• Ensure all clinical activities comply with relevant regulatory guidelines (e.g., FDA, EMA, ISO, etc.).
• Prepare and submit regulatory documents, including clinical study reports, informed consent forms, and IRB submissions.
• Stay up-to-date with changes in regulatory requirements and industry standards to ensure compliance.
• Data Management and Analysis:
• Oversee data collection, management, and analysis to ensure accuracy, integrity, and confidentiality.
• Work with biostatisticians to analyze clinical data and generate reports for internal and external stakeholders.
• Contribute to the development of clinical study protocols, case report forms (CRFs), and data management plans.
• Cross-Functional Collaboration:
• Collaborate with R&D, product development, regulatory affairs, and marketing teams to align clinical objectives with overall company goals.
• Provide clinical insights and feedback during product development and post-market surveillance.
• Communicate study results and clinical insights to internal teams and external partners.
• Patient and Stakeholder Engagement:
• Build and maintain relationships with key opinion leaders (KOLs), healthcare providers, and clinical trial sites.
• Ensure patient safety and ethical considerations are prioritized in all clinical activities.
• Represent the company at conferences, seminars, and meetings with external stakeholders.