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Title
Text copied to clipboard!Clinical Trial Director
Description
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We are looking for a Clinical Trial Director to lead and oversee the planning, execution, and management of clinical trials within our organization. The Clinical Trial Director will be responsible for ensuring that all clinical research activities are conducted in compliance with regulatory requirements, ethical standards, and organizational objectives. This role requires a strategic thinker with extensive experience in clinical research, excellent leadership skills, and the ability to collaborate effectively with cross-functional teams. The Clinical Trial Director will work closely with clinical operations, regulatory affairs, data management, and medical affairs to ensure the successful delivery of clinical programs on time and within budget. Key responsibilities include developing clinical trial protocols, managing budgets and timelines, overseeing site selection and initiation, ensuring patient safety, and maintaining high-quality data standards. The ideal candidate will have a strong background in clinical research, a deep understanding of Good Clinical Practice (GCP) guidelines, and proven experience in managing large, complex clinical trials. This position offers the opportunity to make a significant impact on the development of new therapies and the advancement of medical science.
Responsibilities
Text copied to clipboard!- Lead the planning and execution of clinical trials from start to finish.
- Develop and review clinical trial protocols and study documents.
- Ensure compliance with regulatory requirements and ethical standards.
- Manage clinical trial budgets, timelines, and resources.
- Oversee site selection, initiation, and monitoring activities.
- Collaborate with cross-functional teams including regulatory, data management, and medical affairs.
- Ensure patient safety and data integrity throughout the trial.
- Identify and mitigate risks associated with clinical trials.
- Provide leadership and mentorship to clinical operations staff.
- Prepare and present reports to senior management and stakeholders.
Requirements
Text copied to clipboard!- Advanced degree in life sciences, medicine, pharmacy, or related field.
- Minimum of 8 years of experience in clinical research.
- Proven track record of managing large, complex clinical trials.
- In-depth knowledge of Good Clinical Practice (GCP) and regulatory guidelines.
- Strong leadership and team management skills.
- Excellent communication and interpersonal abilities.
- Ability to manage multiple projects simultaneously.
- Experience with budget management and resource allocation.
- Strong problem-solving and decision-making skills.
- Willingness to travel as needed.
Potential interview questions
Text copied to clipboard!- What is your experience managing large-scale clinical trials?
- How do you ensure compliance with regulatory and ethical standards?
- Describe a challenging situation you faced during a clinical trial and how you resolved it.
- What strategies do you use to manage trial budgets and timelines?
- How do you foster collaboration among cross-functional teams?
- What steps do you take to ensure patient safety in clinical trials?
- How do you handle unexpected issues or delays in a clinical trial?
- What is your approach to risk management in clinical research?
- Can you provide an example of a successful clinical trial you directed?
- How do you stay updated with changes in clinical research regulations?
