Clinical Research Associate (m / w / d)

BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees. Clinical Research Associate 1. Strategic job objectives and measured values Study monitoring :

• a. Objective : Accuracy and completeness of data collected by study site
• b. Objective : Ensure compliance with quality standards and processes.
• c. Objective : Adherence to schedules and deadlines. Safety :
• d. Objective : Ensure compliance with national and local safety reporting requirements. 2. Summary of activities
• Key contact for study sites
• Independent performing of monitoring visits, including site qualification, study site initiation, routine monitoring and study site closure visits
• Complete Investigator Files with all appropriate documentation. Ensure all required documentation is complete prior to site initiation, during enrollment and follow-up, and at site close out
• Train site staff on study
• Mentor and train new or unexpierenced Clinical Research Associates (incl. CRAs from CROs)
• Support national EC / NCA submission
• Support safety reporting 3. Tasks assigned to the position Monitoring
• Perform qualification initiation visits (in collaboration with CPM but also alone as required)
• Perform onsite or remote, as applicable, site initiation visits (in collaboration with CPM but also alone as required)
• Provide training and support to site personnel on study protocols and procedures
• Arrange Monitoring visits at appropriate time intervals (incl. writing confirmation letter) in accordance with the monitoring plan
• Conduct regular visits to clinical trial sites to verify that data entered into the CRFs is consistent with patient medical records, known as source data / document verification (SDV), ensure compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) standards in accordance with the monitoring plan
• Perform close out visits
• Follow-up and resolve any issues arising from monitoring visits
• Document visits by writing visit reports and follow-up letters
• Perform device accountability
• Maintain ISF up to date
• Contribute to document filing
• Query management (incl. safety reporting)
• Preparation and support during safety inspections and audits by regulatory authorities
• International travel
• Build and maintain strong relationships with investigators, site staff, and other stakeholders Clinical Project Management
• Participate in global / local conference calls and meetings to review progress of ongoing trials as well as for training purposesSupport payments of study sites
• Adapt master documents to local requirements (e.g. ICF); check translations
• Support determination of national / local requirements for EC / NCA submissions
• Support national / local submissions to EC / NCA
• Be contact for national / local EC(s) and NCA
• Be the site contact to collect documentation for study submission
• Support Contract negotiations with the site(s) as required to facilitate communication between legal, CPMs and sites Safety
• Collect information of local safety reporting requirements and report to Saftey Officer (SO) at pre-defined timepoints
• Prepare national safety related submission documents to EC / NCA upon request by SO
• Be contact for national EC(s) and NCA regarding safety reporting upon request by SO
• Submission of local safety documentation to EC / NCA upon request by SO
• Follow up with study sites of Safety / Adverse event related tasks upon request by SO
• Ensuring that national / local requirements are met in respect to safety-related documents used and in respect to safety event reporting processes Data protection
• Collect local data protection requirement information and report to CPM prior to study start
• a. Interfaces (internal / external)
• Medical Affairs
• Clinical Data Operations
• CVI / PVI Project Team
• Safety Team
• Clinical Trial Services
• Study sites
• b. Relationships with external third parties (where applicable)
• CRO 4. Special authorizations and / or responsibilities
• Key contact for study sites 5. Job profile
• a. Vocational training (apprenticeship, professional training, studies, etc.)
• Medical related scientific degree (Bachelor, Master, Nursing qualifications etc.)
• Knowledge of the med. tech. sector
• b. Work experiences
• Strong working knowledge and understanding of ISO14155, MDR, ICH-GCP, national laws and regulations governing clinical trials
• 2 years of experience in clinical trial monitoring
• c. Special knowledge, expert knowledge, experiences
• d. Language skills
• Fluent (written and spoken) in main language(s) of allocated country(ies), e.g Hungarian
• Fluent (written and spoken) in English
• Fluent in German
• e. IT skills (appropriate for the position)
• MS Office
• Outlook
• eTMF
• eCRF
• CTMS
• f. Personal-related skills
• High level of attention to detail and strong organizational ability paired with excellent people skills 6. Salary Payment according to the collective agreement with overpay depending on qualifications and professional experience. Start immediately or August / September at the latest. Location : Vienna / Hungary Working hours : Full-time Type of contract : Unlimited Apply now via apply smart Contact : Mag. Christian Hebar We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.