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Title
Text copied to clipboard!Clinical Trials Manager
Description
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We are looking for a dedicated Clinical Trials Manager to lead and oversee the planning, execution, and management of clinical trials. This role involves coordinating with various stakeholders including research teams, regulatory bodies, and sponsors to ensure that clinical studies are conducted efficiently, ethically, and in compliance with all applicable regulations and guidelines. The Clinical Trials Manager will be responsible for managing timelines, budgets, and resources, as well as ensuring data integrity and participant safety throughout the trial process. This position requires strong leadership skills, attention to detail, and a thorough understanding of clinical research methodologies and regulatory requirements. The ideal candidate will have experience in managing multi-center trials and a proven track record of successful study completion.
Responsibilities
Text copied to clipboard!- Plan and oversee clinical trial protocols and procedures.
- Coordinate with research teams, sponsors, and regulatory agencies.
- Manage trial budgets, timelines, and resources effectively.
- Ensure compliance with regulatory requirements and ethical standards.
- Monitor data collection and ensure data quality and integrity.
- Address and resolve issues related to trial conduct and participant safety.
- Prepare and submit regulatory documents and reports.
- Train and supervise clinical research staff.
- Facilitate communication among all stakeholders.
- Evaluate trial progress and implement improvements as needed.
Requirements
Text copied to clipboard!- Bachelor's degree in life sciences, nursing, or related field; advanced degree preferred.
- Proven experience managing clinical trials.
- Strong knowledge of GCP, FDA, and ICH guidelines.
- Excellent organizational and leadership skills.
- Ability to manage multiple projects simultaneously.
- Strong communication and interpersonal skills.
- Proficiency with clinical trial management systems and software.
- Attention to detail and problem-solving abilities.
- Ability to work collaboratively in a multidisciplinary team.
- Understanding of ethical considerations in clinical research.
Potential interview questions
Text copied to clipboard!- What experience do you have managing clinical trials?
- How do you ensure compliance with regulatory requirements?
- Describe a challenge you faced during a clinical trial and how you resolved it.
- How do you manage timelines and budgets in clinical research?
- What strategies do you use to maintain data integrity?
- How do you handle communication among diverse stakeholders?
- What experience do you have with regulatory submissions?
- How do you ensure participant safety during trials?
- Describe your leadership style in managing research teams.
- What clinical trial management systems are you proficient in?
