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.
Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That’s why we need a Clinical Operations Leader like you.
The Clinical Operations Specialist is responsible for supporting the successful execution of clinical studies for all Bioscience products, following ICH-GCP guidelines and all applicable regulatory requirements.
What your responsibilities will be
You will report to the Clinical Operations Manager to align business needs and priorities and meet company goals and objectives.
You will develop and improve Clinical Operations processes to increase the department efficiency and quality standards.
You will communicate and work with other functional groups to identify, review, maintain, align and improve cross-functional processes throughout the clinical programs.
You will interact with the Clinical Operations department staff and project teams to provide guidance to resolve compliance issues.
You will be involved in tasks and decisions related to the development of new technologies for the Clinical Operations department.
You will ensure compliance with GCP / ICH and regulatory guidelines.
Who you are
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
You have a Life Sciences Degree and / or Master.
You speak a high level of English (C1).
You have at least 5 years of experience in clinical trials.
You have a knowledge of ICH GCPs, FDA CFRs, regulatory requirements and understanding of continuous change in the regulatory environment.
You are familiar with Clinical Operations processes, systems and SOPs from the project management point of view.
You like to communicate with your colleagues and the other departments, and you feel comfortable in environments where flexibility and dynamism is required.
You pay attention to detail and prioritize competing tasks to meet deadlines to assure completion of compliance activities.
What we offer
Flexible schedule : Monday-Thursday 7-10 to 16-19h and Friday 8-15h.
Benefits package
Contract of Employment : Permanent position
Flexibility for U Program : 2 days remote working
#J-18808-Ljbffr