Dependable Site Manager well-trained to handle issues with poise. Offering over 25 years of expertise in various roles for organisations health care and pharma industry.
Organised leader equipped with background in business operations. Reviews daily and weekly reporting to proactively identify site challenges. Liaises between stakeholders and management to maintain open communication and support growth.
Overview
28
28
years of professional experience
1
1
Certification
Work history
site manager
Cortex Study Centre
Budapest
06.2022 - 06.2024
participate in the set-up process of the new SMO devision, in the preparation of the needed SOPs, in the yearly revision process and update
participate in HR related tasks like performing interview with potential study coordinators and nurses
liaise and hold connections with physicians in SMO and on another sites/hospitals
support the connections with current CROs and sponsors, and promote the SMO services for new clients
in case of incoming feasibility analyse the details in order to perform the completion of the feasibility in fastest way with the most potential investigators; coordinate the completion and ensure the completion within the timelines
coordinate and supervise the study coordinator’s performance in each clinical trials
in case of need give study specific and GCP based general trainings for the study stuff
coordinate the contracting process between the parties (CRO - SMO and SMO - physicians)
organise the Pt visits and support the study coordinators in performing the Pt visits together with a doctors and nurses
check and ensure the Pt ‘rights and wellbeing based on the Declaration of Helsinki, ICH-GCP and the current regulations
ensure the communication between the site stuff and the sponsors, vendors
ensure that the data entry will be done in time and in the requested quality
prepare the site for audit and/or inspection
follow up the discrepancies, check the CAPA and ensure to solve them in time
clinical research advisor
Semmelweis University
Budapest
03.2021 - 06.2022
participate in the set-up process of research devision, in the preparation of the needed SOPs, in the yearly revision process and update
participate in HR related tasks like performing interview with potential imaging technologist, radiologist, assistants
participate in determining the radiology services and pricing them for the sponsors
liaise and hold connections with PIs and promote services for new potential investigating sites
support the connections with current CROs and sponsors, and promote the radiology services for new clients
participate in setup a new software for managing the running clinic trials from financial, managing and clinical aspects.
in case of incoming request for services analyse the details in order to perform the completion in fastest way with the most potential departments and radiology stuff; coordinate the completion and ensure the completion within the timelines
coordinate and supervise the radiologist and technologist’s performance in each clinical trials
co-owner and managing director
Clinical Research Coordination
Budapest
01.2007 - 03.2021
setup study coordination offices and maintenance in 15 hospitals
cooperation with hospital managements
cooperation with institutional financial management (monthly and yearly performance of Patient visits)
setup a phase1unit and manage the timely qualifications (National Inst. of Oncology)
support the regulatory process of academic trials (IBCSG)
cooperation with institutional medical directors and KOL
communication in a timely manner with onco-teams and database administrators for Patient recruitments
ensure consultancy with international academic associations: e.g. IBCSG, BIG, EORTC, SAKK
setup an internal monitoring system for QC purpose (lead coordination + remote monitoring internal service)
database set-up for recording performance by investigators, hospitals, clinical trials, finance dept.
reporting about institutional internal possibilities and potential investigators for business development
ensure HR related tasks (employee management, general trainings, contracting)
ensure study coordination training course and SI training course
managing company finance, tax and law task
managing board management task (weekly and monthly performance report and meetings)
ensure yearly sponsor meetings about the institutional and company performance
sales representative, transport manager
BnC Group Belgium
Mechelen
01.2001 - 01.2007
Organising and follow-up the transportation of specimens and/or materials, on behalf of B & C Group sa for B & C Customers in Eastern Europe
Ensure that the operational deadlines and quality standards related to the transportation activity are consistently met
Manages the routes for which he is responsible in compliance with contracts, SOPs, WIS, rules and regulations.
Ensures a consistent, timely and efficient preparation and implementation of the routes falling under his responsibility.
Provides efficient and appropriate support for the COR(s) during his/their mission. If required feedbacks any questions and/or issues immediately to the appropriate Project Manager or departmental head.
When required, assists the Director of Operations in the collection and calculation of activity and performance figures.
Ensure that the Specimen Management Department receives all relevant information related to incoming or outgoing specimens
clinical trial manager
Diagnostic Units Hungary SMO
Budapest
01.2001 - 01.2004
Improved patient recruitment methods for more efficient clinical trial enrolment.
Prepared detailed study reports to enhance data accuracy and regulatory compliance.
Managed complex clinical trials, ensuring swift resolution of any arising issues.
Coordinated with various teams for successful completion of clinical studies.
Facilitated training sessions for staff members to improve their understanding of trial protocols.
Monitored progress of clinical trials, quickly addressing any discrepancies or problems.
Maintained ongoing communication with sponsors for transparent reporting on trial status.
Oversaw site management tasks, resulting in smooth conductance of multiple trials simultaneously.
study assistant and co-ordinator
Diagnostic Units Hungary SMO
Budapest
01.1999 - 01.2001
Coordinated study protocols, ensuring compliance with ethical guidelines.
Assisted in planning and implementing research studies to enhance quality of findings.
Monitored study timelines to meet strict deadlines.
Organised regular team meetings for effective collaboration.
Gender Assistant at The Centre for the Study of Violence and Reconciliation (CSVR)Gender Assistant at The Centre for the Study of Violence and Reconciliation (CSVR)
Planning, Monitoring, Evaluation & Learning (PMEL) at Centre for the Study of Adolescence (CSA)Planning, Monitoring, Evaluation & Learning (PMEL) at Centre for the Study of Adolescence (CSA)