We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
We are continually striving to improve the understanding of health care within the local community. Our site in 1100 Vienna (ICON Tower) is a strategic location for the distribution of our high quality and innovative health care products, as well as digitally integrated solutions for our patients and clients. To ensure sustainable company growth, we continually aim to offer attractive career opportunities for more than 170 employees at our Vienna site.
Senior Clinical Research Associate (m/f/d)
- Developing strong site relationships and ensures continuity of site relationships through all phases of the trial
- Performing clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
- Conducting site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner
- Collecting, reviewing, and monitoring required regulatory documentation for study start-up, study maintenance and study close-out
- Communicating with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
- Identifying, assessing and resolving site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed
- Contributing strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required
- B.A./Master`s degree required with strong emphasis in science and/or biology
- Proven CRA experience
- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
- Demonstrated ability to mentor
- Hands on knowledge of Good Documentation Practices
- Proven Skills in Site Management including independent management of site performance and patient recruitment
- Demonstrated high level of monitoring skill with independent professional judgment
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
- Experience with conducting site motivational visit designed to boost site enrollment.
- Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate
- Excellent communication skills in German and English (verbal and written)
- Willingess to travel up to 75% within Austria
We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 56.900,- and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.