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Clinical Operations Specialist
hace 2 meses
Grifols is a global healthcare company that has been improving the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and regions.
About the RoleWe are seeking a Clinical Operations Specialist to support the successful execution of clinical studies for all Bioscience products, following ICH-GCP guidelines and all applicable regulatory requirements.
Key Responsibilities- Report to the Clinical Operations Manager to align business needs and priorities and meet company goals and objectives.
- Develop and improve Clinical Operations processes to increase department efficiency and quality standards.
- Communicate and work with other functional groups to identify, review, maintain, align, and improve cross-functional processes throughout clinical programs.
- Interact with Clinical Operations department staff and project teams to provide guidance to resolve compliance issues.
- Be involved in tasks and decisions related to the development of new technologies for the Clinical Operations department.
- Ensure compliance with GCP/ICH and regulatory guidelines.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required.
- Have a Life Sciences Degree and/or Master.
- Have at least 3 years of experience in clinical trials (site monitor or CRA preferred).
- Speak and write English fluently.
- Have a knowledge of ICH GCPs, FDA, EMA, and CFRs regulatory requirements and understanding of continuous change in the regulatory environment.
- Be familiar with Clinical Operations processes, systems, and SOPs, needed for the conduct of a clinical study.
- Like to communicate with colleagues and other departments and feel comfortable in environments where flexibility and dynamism are required.
- Be highly detail-oriented and have good organization and time-management skills.
Grifols is committed to maintaining an atmosphere that encourages all employees to develop their professional careers in an excellent working environment. We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
