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Title
Text copied to clipboard!Clinical Study Manager
Description
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We are looking for a dedicated Clinical Study Manager to lead and coordinate clinical trials from initiation through completion. The ideal candidate will have extensive experience in managing clinical research projects, ensuring adherence to regulatory requirements, and maintaining high standards of data integrity and patient safety. This role involves close collaboration with cross-functional teams including clinical operations, data management, regulatory affairs, and medical writing. The Clinical Study Manager will be responsible for planning study timelines, managing budgets, overseeing site selection and monitoring, and ensuring timely and accurate reporting of study results. Strong leadership, communication, and problem-solving skills are essential to successfully navigate the complexities of clinical research and deliver high-quality outcomes that support drug development and regulatory submissions. If you are passionate about advancing medical science and have a proven track record in clinical trial management, we invite you to join our team and contribute to innovative healthcare solutions.
Responsibilities
Text copied to clipboard!- Plan and manage all phases of clinical trials.
- Coordinate with clinical sites and investigators.
- Ensure compliance with regulatory guidelines and protocols.
- Monitor study progress and resolve issues promptly.
- Manage study budgets and resource allocation.
- Prepare and review study documentation and reports.
- Collaborate with cross-functional teams to ensure study success.
- Oversee data collection and quality assurance processes.
- Train and supervise clinical research staff.
- Facilitate communication between stakeholders and sponsors.
Requirements
Text copied to clipboard!- Bachelor's degree in life sciences, nursing, or related field.
- Minimum 5 years experience in clinical trial management.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
- Excellent organizational and project management skills.
- Proficient in clinical trial management systems (CTMS).
- Effective communication and leadership abilities.
- Ability to analyze and interpret clinical data.
- Experience with budget management and contract negotiation.
- Problem-solving skills and attention to detail.
- Willingness to travel to clinical sites as needed.
Potential interview questions
Text copied to clipboard!- Describe your experience managing clinical trials.
- How do you ensure compliance with regulatory standards?
- Can you provide an example of resolving a complex issue during a study?
- What strategies do you use for effective team coordination?
- How do you manage study timelines and budgets?
- Explain your familiarity with clinical trial management software.
