
Clinical Research Manager
Há 3 dias
This role involves overseeing site activation activities at a country level. You will perform tasks associated with regulatory compliance, project requirements, and standard operating procedures.
Main Responsibilities:- You will serve as the Single Point of Contact (SPOC) for investigative sites, managing interactions between them, Site Activation Managers, Project Management teams, and other departments.
- Perform start-up and site activation tasks according to applicable regulations, ensuring adherence to SOPs and work instructions.
- Prepare and review regulatory documents for completeness and accuracy, distributing them to sites and internal teams.
- Manage internal systems, databases, and tracking tools to ensure accurate completion and maintenance of project-specific information.
- Review site performance metrics and provide feedback to management on areas for improvement.
- Establish and agree on project planning and timelines, implementing contingency plans as needed.
- Maintain communication with team members regarding completion of regulatory and contractual documents for individual sites.
- Track progress, approval, and execution of documents, including ethics, informed consent forms, and investigator packs, in line with project timelines.
- Provide local expertise to Site Activation Managers and project teams during initial and ongoing project planning.
- Perform quality control of documents provided by sites.
- Bachelor's Degree in life sciences or a related field and 3 years' clinical research experience, or equivalent combination of education, training, and experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Effective communication, organizational, and interpersonal skills.
- Ability to work independently and prioritize tasks effectively.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Understanding of regulated clinical trial environment and drug development process.
We are a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. Our goal is to accelerate medical treatment development and improve patient outcomes worldwide.
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