Title: Clinical Trial Manager
Company: Caldera Medical
Location: Los Angeles, CA
As part of our commitment to improving women’s health, we are conducting a postmarket surveillance study to ensure the safety of our products. We are currently seeking a skilled and motivated Clinical Trial Manager to join our team and play a vital role in advancing women’s healthcare.
As a Clinical Trial Manager at Caldera Medical, you will be responsible for overseeing the planning, execution, and management of clinical trials related to our women’s health medical devices. You will work closely with cross-functional teams, including clinical research associates, regulatory and quality, and external partners, to ensure the successful conduct of clinical studies in compliance with relevant regulations and guidelines.
- Clinical trial execution: Ensure current clinical trial plans meet scientific and ethical standards
- Project Management: Lead and manage all aspects of clinical trials from initiation to completion. Develop and maintain project timelines, milestones, and budgets. Monitor progress and promptly address any issues or delays to keep the study on track.
- Regulatory Compliance: Ensure all trials comply with applicable regulatory guidelines, including but not limited to FDA regulations, ICH/GCP, and ISO standards. Oversee preparation of trial-related documentation to regulatory authorities and IRBs.
- Site Management: Manage team of clinical research associates. Provide guidance and support to internal and external staff to ensure adherence to study protocols, data collection, and study participant retention.
- Contractor and Vendor Management: Coordinate with any external vendors, contract research organizations, or other third-party partners involved in the execution of clinical trials. Evaluate performance and ensure quality deliverables.
- Data Management: Work closely with Clinical team to oversee data collection, validation, and analysis. Review and interpret trial data, ensuring accuracy and completeness for regulatory submissions.
- Safety and Risk Management: Monitor participant safety and report any adverse events in accordance with safety reporting guidelines. Implement risk management strategies to minimize potential issues throughout the trial.
- Quality Control and Assurance: Work closely with VP of Quality and Regulatory to implement quality control processes to ensure compliance with industry standards, study protocols, and GCP guidelines.
- Communication and Collaboration: Facilitate effective communication between internal and external stakeholders. Prepare regular progress reports for management and other relevant teams.
- Continuous Improvement: Contribute to process improvement initiatives to optimize clinical trial operations, and enhance efficiency.
Minimum Qualifications and Requirements:
● Bachelor’s degree in life sciences, healthcare, or a related field.
● Minimum of 5 years experience in clinical trial management, preferably within the medical device industry and women’s health or gynecology.
● Thorough understanding of FDA regulations, ICH/GCP, ISO related to clinical trials.
● Experience in managing Post Market surveillance trials from planning to completion.
● Strong project management skills, including the ability to manage multiple tasks and prioritize effectively.
● Excellent leadership and communication skills, with the ability to work collaboratively with cross-functional teams and external partners.
● Proficiency in using clinical trial software and tools
● Detail-oriented, with a focus on data accuracy and compliance
● Flexibility and adaptability to evolving project needs and timelines.
To apply for this position or to learn more, please click "Apply Online" below.
SOCRA Exp: 9/30/2023