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Clinical Operations Manager

2 months ago

Singapore MyCareersFuture Full time
Job Description

MyCareersFuture is seeking a highly skilled Clinical Manager to join our team in Singapore. As a Clinical Manager, you will be responsible for leading the planning, design, and execution of clinical studies and trials to support product development and regulatory submissions.

Key Responsibilities:
  • Clinical Trial Management:
    • Develop and implement clinical trial strategies to ensure successful product development and regulatory submissions.
    • Collaborate with cross-functional teams to manage clinical trial operations, including site selection, patient recruitment, and data collection.
    • Monitor study progress, including timelines, budgets, and milestones, and report to senior management.
  • Regulatory Compliance:
    • Ensure all clinical activities comply with relevant regulatory guidelines, including FDA, EMA, and ISO standards.
    • 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.
Requirements:
  • 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.