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Title
Text copied to clipboard!Clinical Research Manager
Description
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We are looking for a dedicated and experienced Clinical Research Manager to join our team. The ideal candidate will be responsible for overseeing and managing clinical research projects from inception to completion. This role requires a deep understanding of clinical research protocols, regulatory requirements, and the ability to lead a team of researchers and coordinators. The Clinical Research Manager will ensure that all clinical trials are conducted in compliance with regulatory standards and company policies. This position involves close collaboration with various departments, including medical, regulatory, and data management teams, to ensure the successful execution of clinical trials. The successful candidate will have excellent organizational skills, attention to detail, and the ability to manage multiple projects simultaneously. They will also be responsible for developing and maintaining relationships with key stakeholders, including investigators, sponsors, and regulatory authorities. The Clinical Research Manager will play a crucial role in the development of new therapies and treatments, contributing to the advancement of medical science and patient care. This position offers an exciting opportunity to work in a dynamic and fast-paced environment, with the potential for significant impact on the future of healthcare.
Responsibilities
Text copied to clipboard!- Oversee the planning, implementation, and management of clinical research projects.
- Ensure compliance with regulatory requirements and company policies.
- Develop and maintain study protocols, informed consent forms, and other study-related documents.
- Coordinate with cross-functional teams, including medical, regulatory, and data management.
- Monitor study progress and ensure adherence to timelines and budgets.
- Manage and mentor a team of clinical research coordinators and assistants.
- Develop and maintain relationships with investigators, sponsors, and regulatory authorities.
- Ensure accurate and timely data collection, entry, and reporting.
- Conduct site visits and audits to ensure compliance with study protocols.
- Prepare and present study updates and reports to senior management.
- Identify and mitigate risks associated with clinical research projects.
- Ensure proper documentation and archiving of study materials.
- Participate in the development of new research proposals and grant applications.
- Stay current with industry trends and advancements in clinical research.
- Provide training and support to research staff and study sites.
Requirements
Text copied to clipboard!- Bachelor's degree in a related field; advanced degree preferred.
- Minimum of 5 years of experience in clinical research management.
- Strong knowledge of clinical research protocols and regulatory requirements.
- Excellent organizational and project management skills.
- Ability to manage multiple projects simultaneously.
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
- Attention to detail and strong analytical skills.
- Proficiency in Microsoft Office and clinical trial management software.
- Ability to travel as needed for site visits and meetings.
- Experience with budget management and financial reporting.
- Knowledge of Good Clinical Practice (GCP) guidelines.
- Ability to work independently and as part of a team.
- Strong problem-solving and decision-making skills.
- Commitment to ethical research practices and patient safety.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with managing clinical research projects?
- How do you ensure compliance with regulatory requirements in clinical trials?
- Can you provide an example of a challenging project you managed and how you overcame obstacles?
- How do you handle conflicts within your team or with external stakeholders?
- What strategies do you use to ensure accurate and timely data collection?
- How do you stay current with industry trends and advancements in clinical research?
- Can you describe your experience with budget management in clinical research?
- How do you ensure effective communication and collaboration with cross-functional teams?
- What is your approach to risk management in clinical research projects?
- How do you mentor and support your team members?