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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 to lead and coordinate all aspects of clinical trials to ensure they are conducted in compliance with regulatory requirements and company standards. The Clinical Trial Manager will be responsible for planning, executing, and closing clinical studies, working closely with cross-functional teams including clinical operations, regulatory affairs, data management, and biostatistics. This role requires strong leadership, organizational, and communication skills to manage timelines, budgets, and quality standards.
The ideal candidate will have a deep understanding of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulatory requirements. They will be responsible for selecting and managing vendors, overseeing site selection and initiation, monitoring progress, and ensuring timely delivery of study milestones. The Clinical Trial Manager will also be expected to identify and mitigate risks, resolve issues, and provide regular updates to senior management.
In addition to operational oversight, the Clinical Trial Manager will contribute to protocol development, review case report forms (CRFs), and ensure proper documentation and reporting. They will also play a key role in training and mentoring junior staff, fostering a culture of continuous improvement and compliance.
This position offers the opportunity to work on innovative therapies and make a meaningful impact on patient outcomes. If you are passionate about clinical research and have a proven track record of managing successful trials, we encourage you to apply.
Responsibilities
Text copied to clipboard!- Plan, initiate, and manage clinical trials from start to finish
- Ensure compliance with GCP, ICH, and regulatory requirements
- Oversee site selection, initiation, monitoring, and close-out activities
- Manage study timelines, budgets, and resources
- Coordinate with cross-functional teams and external vendors
- Monitor trial progress and address issues proactively
- Prepare and present study updates to stakeholders
- Review and approve study-related documents and reports
- Train and mentor clinical research staff
- Ensure proper documentation and data integrity
Requirements
Text copied to clipboard!- Bachelor’s degree in life sciences or related field; advanced degree preferred
- Minimum 5 years of experience in clinical trial management
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements
- Experience with CRO and vendor management
- Excellent organizational and project management skills
- Strong communication and leadership abilities
- Proficiency in clinical trial management systems (CTMS)
- Ability to travel as needed
- Detail-oriented with strong problem-solving skills
- Ability to work independently and in a team environment
Potential interview questions
Text copied to clipboard!- How many years of experience do you have managing clinical trials?
- Can you describe your experience with GCP and ICH guidelines?
- Have you worked with CROs or external vendors before?
- What therapeutic areas have you worked in?
- How do you handle delays or issues during a clinical trial?
- What clinical trial management systems are you familiar with?
- Are you comfortable traveling for site visits?
- Can you provide an example of a successful trial you managed?
- How do you ensure compliance with regulatory requirements?
- What is your approach to team leadership and mentoring?
