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Title
Text copied to clipboard!Clinical Research Manager
Description
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We are looking for a Clinical Research Manager to lead our dynamic team in the planning, execution, and management of our clinical research projects. The ideal candidate will have a strong background in clinical research, with a proven track record of successful project management and team leadership. As a Clinical Research Manager, you will be responsible for overseeing the development and implementation of research protocols, ensuring compliance with regulatory standards, and managing the day-to-day operations of clinical trials. You will work closely with cross-functional teams, including medical affairs, regulatory affairs, and data management, to ensure that research objectives are met on time and within budget. Your role will also involve stakeholder engagement, including working with external partners and sponsors, to facilitate the successful completion of research projects. With your expertise, you will play a crucial role in advancing our research goals and contributing to the development of innovative healthcare solutions.
Responsibilities
Text copied to clipboard!- Develop and implement clinical research project plans, including timelines, budgets, and resource allocation.
- Ensure compliance with all regulatory and ethical standards for clinical research.
- Manage the selection, training, and supervision of research staff and teams.
- Oversee patient recruitment and consent processes, ensuring adherence to protocol criteria.
- Monitor the progress of clinical trials, identifying and addressing any issues that arise.
- Liaise with external partners, sponsors, and stakeholders to ensure project objectives are met.
- Prepare and submit regulatory documents and reports as required.
- Analyze data from clinical trials and contribute to the preparation of manuscripts for publication.
- Stay abreast of developments in clinical research methodologies and regulations.
- Facilitate communication and collaboration among project teams and departments.
Requirements
Text copied to clipboard!- Bachelor's degree in life sciences, nursing, or related field; Master's degree preferred.
- Minimum of 5 years of experience in clinical research, with at least 2 years in a managerial role.
- Strong understanding of clinical research protocols, GCP, and regulatory requirements.
- Proven track record of managing clinical research projects and teams.
- Excellent organizational, leadership, and communication skills.
- Ability to work effectively in a fast-paced, multidisciplinary environment.
- Experience with clinical trial management software and data analysis tools.
- Detail-oriented with strong problem-solving skills.
- Flexibility to travel as required for project needs.
- Certification in clinical research (e.g., CCRC, CCRP) is an advantage.
Potential interview questions
Text copied to clipboard!- Can you describe your experience in managing clinical research projects?
- How do you ensure compliance with regulatory and ethical standards in your projects?
- What strategies do you use for effective team management and leadership?
- Can you give an example of a challenging clinical trial you managed and how you overcame the challenges?
- How do you stay updated with the latest developments in clinical research methodologies and regulations?
- Describe your experience with clinical trial management software and data analysis tools.
- How do you handle conflicts within your research team?
- What is your approach to managing budgets and resources for clinical research projects?
- How do you ensure effective communication and collaboration among cross-functional teams?
- What motivates you to work in the field of clinical research?