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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 and coordinate clinical research projects across various therapeutic areas. This role is pivotal in ensuring that clinical trials are conducted in accordance with regulatory requirements, ethical standards, and company policies. The Clinical Research Manager will oversee the planning, execution, and completion of clinical studies, working closely with cross-functional teams including clinical operations, regulatory affairs, data management, and biostatistics.
The ideal candidate will have a strong background in clinical research, excellent leadership skills, and a deep understanding of Good Clinical Practice (GCP) guidelines. You will be responsible for managing timelines, budgets, and resources to ensure successful delivery of clinical trials. This includes selecting and managing clinical research sites, monitoring study progress, and ensuring data integrity and compliance.
In this role, you will also be expected to mentor and supervise clinical research associates and other team members. You will contribute to protocol development, review study documentation, and liaise with investigators, sponsors, and regulatory authorities. Strong communication and problem-solving skills are essential, as you will be the primary point of contact for internal and external stakeholders.
This is an exciting opportunity for a motivated professional to make a significant impact in the field of clinical research. If you are passionate about advancing medical science and improving patient outcomes, we encourage you to apply.
Responsibilities
Text copied to clipboard!- Manage and oversee clinical research projects from initiation to completion
- Ensure compliance with regulatory guidelines and GCP standards
- Develop and manage study budgets and timelines
- Select, train, and monitor clinical research sites
- Coordinate with cross-functional teams to support study execution
- Review and approve study protocols and related documents
- Monitor study progress and address issues proactively
- Serve as primary liaison with investigators and regulatory bodies
- Ensure data quality and integrity throughout the study
- Mentor and supervise clinical research staff
Requirements
Text copied to clipboard!- Bachelor’s degree in life sciences or related field (Master’s or PhD preferred)
- Minimum 5 years of experience in clinical research
- Strong knowledge of GCP and regulatory requirements
- Proven leadership and project management skills
- Excellent communication and interpersonal abilities
- Ability to manage multiple projects simultaneously
- Experience with electronic data capture systems
- Detail-oriented with strong analytical skills
- Ability to travel as needed
- Certification in clinical research (e.g., ACRP, SOCRA) is a plus
Potential interview questions
Text copied to clipboard!- How many years of experience do you have in clinical research?
- Have you managed clinical trials from start to finish?
- What therapeutic areas have you worked in?
- Are you familiar with GCP and FDA regulations?
- Have you supervised clinical research staff before?
- What is your experience with budget and timeline management?
- Do you have experience working with CROs and vendors?
- Are you willing to travel for site visits?
- What electronic data capture systems have you used?
- Do you hold any clinical research certifications?
