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Title
Text copied to clipboard!Clinical Trial Manager
Description
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We are looking for a Clinical Trial Manager who will be responsible for overseeing and managing clinical trials from initiation to completion. The ideal candidate will ensure that all trials are conducted in compliance with regulatory requirements, ethical standards, and company policies. You will coordinate with cross-functional teams, including clinical research associates, investigators, regulatory affairs, and data management teams, to ensure smooth execution of clinical trials. Your role will involve planning, budgeting, monitoring, and reporting on clinical trial progress, as well as identifying and mitigating risks. You will also be responsible for maintaining accurate documentation and records, ensuring data integrity, and preparing reports for regulatory submissions. The Clinical Trial Manager will serve as the primary point of contact for clinical trial sites, vendors, and internal stakeholders, providing guidance and support throughout the trial lifecycle. You will be expected to stay current with industry trends, regulatory changes, and best practices in clinical trial management. Additionally, you will contribute to the development and implementation of standard operating procedures (SOPs) and training programs to enhance the efficiency and quality of clinical trial operations. The successful candidate will possess strong leadership, organizational, and communication skills, with the ability to manage multiple projects simultaneously. You should have a thorough understanding of clinical trial processes, regulatory requirements, and ethical considerations. Experience in managing clinical trials across various therapeutic areas and phases is highly desirable. You will be expected to demonstrate problem-solving abilities, attention to detail, and a commitment to continuous improvement. The Clinical Trial Manager will play a critical role in ensuring the successful execution of clinical trials, contributing to the advancement of medical research and the development of innovative therapies. This position offers an exciting opportunity to work in a dynamic and collaborative environment, where your expertise and contributions will be valued and recognized. If you are passionate about clinical research and committed to excellence, we encourage you to apply and join our dedicated team.
Responsibilities
Text copied to clipboard!- Plan, initiate, and manage clinical trials from start to finish.
- Ensure compliance with regulatory guidelines, ethical standards, and company policies.
- Coordinate with clinical research associates, investigators, and other stakeholders.
- Monitor trial progress, identify risks, and implement mitigation strategies.
- Maintain accurate documentation and ensure data integrity throughout the trial.
- Prepare and submit reports to regulatory authorities and internal stakeholders.
- Develop and implement standard operating procedures (SOPs) and training programs.
- Serve as the primary contact for clinical trial sites and vendors.
Requirements
Text copied to clipboard!- Bachelor's degree in life sciences, healthcare, or related field; advanced degree preferred.
- Minimum of 3-5 years of experience managing clinical trials.
- Strong knowledge of clinical trial regulations, guidelines, and ethical standards.
- Excellent organizational, leadership, and communication skills.
- Ability to manage multiple projects simultaneously and meet deadlines.
- Proficiency in clinical trial management software and data management systems.
- Experience in various therapeutic areas and clinical trial phases preferred.
- Strong problem-solving skills and attention to detail.
Potential interview questions
Text copied to clipboard!- Can you describe your experience managing clinical trials from initiation to completion?
- How do you ensure compliance with regulatory requirements and ethical standards in clinical trials?
- What strategies do you use to identify and mitigate risks during clinical trials?
- How do you handle conflicts or challenges with clinical trial sites or vendors?
- Can you provide an example of a successful clinical trial you managed and what contributed to its success?
