Clinical Trial Operations Manager
4 days ago
About Simcere Zaiming:
Simcere Zaiming is a pioneering pharmaceutical company dedicated to advancing healthcare through cutting-edge research and innovative therapies. With a focus on oncology drug development, we are committed to improving the lives of patients in China and worldwide. Our culture values sincerity, collaboration, result orientation, and a relentless pursuit of scientific excellence.
Job Summary:
We are seeking an experienced and detail-oriented Clinical Trial Manager to oversee and manage clinical trials from start to finish. The ideal candidate will ensure that all trials are conducted in compliance with regulatory requirements, company policies, and ethical standards. This role involves collaboration with cross-functional teams, management of timelines and budgets, and ensuring the integrity of clinical data.
Key Responsibilities:
- Plan, initiate, and oversee clinical trials to ensure adherence to protocols and regulatory requirements.
- Develop and manage trial budgets, timelines, and resources.
- Coordinate with investigators, site staff, and vendors to ensure smooth execution of trials.
- Monitor trial progress, including patient recruitment, data collection, and adherence to protocols.
- Ensure compliance with Good Clinical Practice (GCP), FDA regulations, and other relevant guidelines.
- Prepare and maintain comprehensive trial documentation, including trial master files, monitoring reports, and regulatory submissions.
- Manage and mentor clinical trial staff, providing training and support as needed.
- Conduct risk assessments and develop mitigation strategies.
- Facilitate communication and information flow between all stakeholders.
- Review and approve trial-related documents and reports.
- Address and resolve any issues or discrepancies that arise during trials.
- Ensure data integrity and quality, overseeing data management and analysis processes.
- Stay updated on industry trends and advancements to implement best practices in clinical trial management.
Requirements:
- Bachelor's degree in life sciences, nursing, or a related field (advanced degree preferred).
- Minimum of 5 years of experience in clinical trial management or a related role.
- Comprehensive understanding of clinical trial processes, GCP, and FDA regulations.
- Proven ability to manage multiple trials simultaneously, with strong organizational skills.
- Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
- Proficiency in clinical trial management systems (CTMS) and other relevant software.
- Strong problem-solving skills and attention to detail.
- Ability to travel as needed for trial oversight and management.
Preferred Qualifications:
- Certification in clinical research (e.g., CCRA, CCRC, or equivalent).
- Experience in a specific therapeutic area relevant to the company's focus.
- Previous experience working in a CRO or pharmaceutical company.
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