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The Senior Clinical Research Associate will perform site selection, initiation, monitoring, and close-out visits while ensuring adherence to GCP and ICH guidelines. They will also manage study progress by tracking regulatory submissions, recruitment, and data integrity across various clinical trials.
Join IQVIA as a SrCRA II/III (m/w/d) in our Clinical Site Management department home-based throughout Germany. You will focus on a comprehensive clinical trial management in a variety of indications and learn about the diverse scientific approach of the sponsors. Beside establishing strong relationships with the global study team and the involved investigators, you will conduct monitoring on complex clinical trials for different pharma companies and assure their adherence to good clinical practices and study protocols.
With strategic site relationship managers supporting you throughout your role, this is a fantastic opportunity for you to embed yourself in the wider clinical operations team and work on ground-breaking new medicine development.
Your responsibilities will include:
Performing site selection, initiation, monitoring and close-out visits.
Supporting the development of a subject recruitment plan.
Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
Collaborating with experts on study sites and client representatives.
Qualifications:
University Degree in life science or other scientific discipline or apprenticeship in health care.
Minimum of six years of on-site monitoring experience
Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Strong written and verbal communication skills, attention to detail and ability to work in a fast pace environment.
Good command of German and English.
Flexibility to business travel up to 60% of working time.
Driver’s license class B.
What you can expect:
Resources that promote your career growth.
Leaders that support flexible work schedules.
Programs to help you build your therapeutic knowledge.
Dynamic work environments that expose you to new experiences.
Home-office, company car/car allowance, accident insurance, pension and more.
Whatever your career goals, we are here to ensure you get there!
Please apply with your English CV and motivation letter.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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