Clinical Research Manager

5日前

Japan Jobgether
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Clinical Research Manager - REMOTE. In this role, you will oversee the strategic and operational oversight of clinical trials across different phases, ensuring compliance with regulatory requirements and guidelines. You will manage cross-functional teams, monitor timelines and budgets, and serve as the primary liaison among various stakeholders. Your expertise will shape the direction of clinical projects, making a significant impact on the research landscape, while supporting the team's growth and operational efficiency.

Accountabilities

  • Lead the planning, execution, and management of clinical trials across multiple therapeutic areas and phases.
  • Oversee site selection, study start-up, patient recruitment, data collection, and close-out activities.
  • Ensure compliance with FDA, ICH-GCP, and other applicable regulatory standards.
  • Develop and maintain project timelines, budgets, and resource plans.
  • Supervise and mentor Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), and study coordinators.
  • Review and approve study documentation including protocols, CRFs, informed consent forms, and monitoring reports.
  • Coordinate with cross-functional teams including regulatory affairs, data management, biostatistics, and medical writing.
  • Manage vendor and CRO relationships, including contract negotiations and performance monitoring.
  • Track and report on study metrics and provide regular updates to senior leadership.
  • Oversee the preparation and conduct of audits and regulatory inspections.

Requirements

  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field (Master's or Ph.D. preferred).
  • Minimum of 5–7 years of experience in clinical research, including 2+ years in a managerial or supervisory role.
  • In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
  • Proven experience managing Phase I-IV trials across multiple therapeutic areas.
  • Strong project management, leadership, and team coordination skills.
  • Excellent written and verbal communication abilities.
  • Proficiency with clinical trial software (e.g., CTMS, EDC, eTMF platforms).
  • Ability to travel up to 20% as needed.

Benefits

  • Dynamic and collaborative work environment.
  • Comprehensive benefits package including paid holidays and Paid Time Off (PTO).
  • Medical insurance to ensure flexibility and coverage.
  • Support for professional and personal growth.
  • Opportunities to join a network of Subject Matter Experts.
Why Apply Through Jobgether? We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team We appreciate your interest and wish you the best Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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