Senior-Principal Clinical Research Associate
Our Client is a leading Clinical Research CRO across Phases I-IV, they have been providing vital services for their extensive client list for decades. Established international they have experts across multiple functions in life sciences with over a dozen therapeutic areas in their area of expertise, with a presence of in over 40 countries.
In this company you can grow and develop your own skill set in a large variety of different functions and therapy areas. Additionally you know that the projects you will be working on will provide a benefit to millions of people of people.
Austria, with travel across the DACH Region
- Take the lead in monitoring vital sites across the DACH region
- Conduct qualification, initiation, monitoring, and closeout visits for research sites
- High level of communication with medical site staff including coordinators, clinical research physicians
- Verifying investigator qualifications, training and resources, including facilities, laboratories
- Medical record and research source documentation verification against case report form data and applicable regulatory requirements;
- Verification of the enrolment of eligible subjects for the sites
- Adverse events verification and review, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
- Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
- Life Sciences education – for example BSc, PhD
- Ideally coming from a background as a Clinical Research Associate
- Proven track record of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF, documentation to be submitted to competent authorities.
- High level of site management
- Outstanding communication and Presentation skills;
- Must be detail-oriented and efficient in time management;
- Excellent verbal and written communication skills in English and German;
Interested in learning more? Then don’t hesitate to apply! I’ll be looking forward to discussing the role with you.