Peter Augustín Email & Phone Number

Bratislava, Slovakia

Bratislava, Slovakia

• Activities specified for the below job titles.• Subject Matter Expert (SME) for Clinical Development Analytics (CDA) system• Main focus on Global Lead Monitoring activities and mentoring activities• Mentor of junior Lead Monitors• Microsoft SharePoint site / pages content developer

Bratislava, Slovakia

• Activities specified for the Associate Clinical Research Monitor job.• Intensive mentoring and new hires training.• Hiring process involvement.• Assist sites/study teams with audit preparation.• Implementing of CAPA (Corrective And Preventive Action) into practice after audit.• Lead Monitor responsibilities for Global study: • Monitoring Plan creation and update, Monitoring Visits Reports templates and Monitoring Visits Letters (Pre–Visit Confirmation, Follow–Up) creation and revision • Trending meeting preparation • Input on Clinical Investigational Plan and other study documents • Monitors´ trainings • Active participation during study team / monitoring meetings.• Coordinator for Monitor Time Tracker Tool for EMEA APAC region (oversight of correct entering, corrections of the records, training new hires, involvement in the creation of the guidelines documents).• Preparation of regional meetings (agenda, logistics, program, team-building activities).• Presentations / trainings during the regional meetings.• Provide input into the development and improvement of investigator and site management systems (e.g., CTMS, MTTT, RAD).• Persistent improving of monitoring daily tasks.

Bratislava, Slovakia

• Monitoring activities covering all phases from Start-up until Study Closure (pre-market and post-market studies) in 3 countries: Slovakia, Czech Republic, Hungary• Collaboration with KOLs from 3 countries on daily basis: Slovakia, Czech Republic, Hungary• Cross–business portfolio within Medtronic (Cardiac Heart and Rhythm Failure, Aortic – Peripheral – Vascular, Spine, Coronary and Structural Heart, Atrial Fibrillation Solutions) • Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Clinical Investigation Plan, Monitoring Plan, applicable regulatory, Ethics Committee (EC), and Medtronic standards, guidelines and policies and business policies.• Communicate visit findings with site personnel and internal employees (study team, management).• Complete a written letters for distribution to the Investigator and appropriate site personnel for follow-up.• Prepare site visit reports and correspondence for all visits conducted in accordance with the study documents.• Act as a primary point of contact for study sites and identify site needs, provide solutions to facilitate the clinical study process.• Perform initial and ongoing site personnel training as required.• Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to Clinical Investigation Plan, applicable regulations, Good Clinical Practices and Standard Operating Procedures.• Propose solutions and collaborate with monitoring management and study team personnel towards securing Investigator compliance.• Possess understanding of regulatory requirements• EC & CA preparation, submission, follow-up in 3 countries (Slovakia, Czech Republic, Hungary)• Clinical trial agreement process – preparation, negotiation and communication with site personnel, communication with internal team, implementing of the site´s requests (2 countries: Slovakia, Czech Republic)• Adhere to all applicable Medtronic policies and procedures

Bratislava, Slovakia

• Part - time job• Expert technical translations of the patents (mainly pharmaceutical) from/to English• Expert corrections and checking of the translations (chemistry field)

Doctor Of Philosophy - Phd, Inorganic Chemistry

Master Of Engineering - Meng, Technical Chemistry

Bachelor Of Science - Bs, Chemistry And Medical Chemistry