Summary
Overview
Work history
Education
Skills
Languages
Affiliations
Certification
Custom
Personal Information
References
Timeline
Generic

Attila Kiss

Solymár,Pest megye

Summary

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.
  • Managed participant recruitment processes, boosting enrolment rates.
  • Supervised collection, analysis and interpretation of data for accurate results.
  • Ensured adherence to Good Clinical Practice guidelines in all phases of studies.
  • Trained new staff members on study protocols, enabling seamless integration into the team.
  • Administered injections, took blood samples to aid in accurate diagnosis.
  • Assisted doctors during procedures, ensuring successful operations.
  • Managed ward supplies for seamless healthcare delivery.

assistant, Department of Cardiology and ICU

Haynal Imre University of Health Sciences
Budapest
01.1996 - 01.1999
  • Carried out day-to-day duties accurately and efficiently.
  • Quickly learned and applied new skills to daily tasks, improving efficiency and productivity.
  • Successfully delivered on tasks within tight deadlines.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Administered critical care to patients, improving their overall health condition.
  • Collaborated with medical teams for accurate and efficient patient diagnosis.
  • Monitored vital signs of critically ill patients, ensuring stability.
  • Assessed the needs of ICU patients, providing appropriate nursing interventions.
  • Ensured safe environment by adhering to infection-control policies and protocols.
  • Facilitated communication between patients' families and physicians for better understanding of medical conditions.
  • Coordinated with interdisciplinary team to provide holistic care to patients.
  • Operated life-supporting machines, guaranteeing patient viability in challenging situations.
  • Handled emergency situations effectively under high pressure environments, preserving patient lives.

Education

Healthcare Manager - Healthcare management

Semmelweis University
Budapest, Hungary
09/2000 - 08/2002

Bachelor of Science - Faculty of Health Sciences

Haynal Imre University of Health Sciences
Budapest, Hungary
09/1995 - 06/1999

Secondary School -

Táncsics Mihály Secondary School
Mor, Fejér
09/1991 - 06/1995

different courses of company management - time management, change management, GDPR and communication

01.2007 - 1 2020

Skills

  • Ethical understanding
  • Electronic health records system
  • Therapeutic area expertise
  • Patient recruitment strategies
  • Regulatory compliance awareness
  • Informed consent process management
  • Data collection techniques
  • IRB submission processes
  • Pharmacovigilance procedures
  • Organisational alignment
  • Clinical trial management systems
  • Good clinical practice
  • Multitasking efficiency
  • FDA regulation familiarity
  • Medical terminology
  • Screening process knowledge
  • Patient scheduling
  • Recruitment strategies
  • Case report form (CRF) development
  • Clinical oversight
  • Patient assessment
  • Project leadership
  • Budgeting and financial reporting
  • Quality Assurance (QA) controls
  • Performance metrics
  • Personnel Management
  • Knowledge of regulatory compliance
  • Clear vision casting
  • Contractual negotiation
  • Capital budgeting
  • Leadership excellence
  • Change implementation
  • Profit and loss reporting
  • Market trend analysis
  • Performance evaluation
  • Business administration
  • Operations management
  • Financial management

Languages

English
Advanced
German
Elementary

Affiliations

  • Yoga practising
  • Riding bicycle
  • Trekking in mountains
  • Gardening

Certification

Driving licence category B

Custom

01/01/07, 01/01/20, different courses of company management, time management, change management, GDPR and communication

Personal Information

  • Date of birth: 01/01/77
  • Nationality: Hungarian

References

References available upon request.

Timeline

site manager

Cortex Study Centre
06.2022 - 06.2024

clinical research advisor

Semmelweis University
03.2021 - 06.2022

co-owner and managing director

Clinical Research Coordination
01.2007 - 03.2021

different courses of company management - time management, change management, GDPR and communication

01.2007 - 1 2020

sales representative, transport manager

BnC Group Belgium
01.2001 - 01.2007

clinical trial manager

Diagnostic Units Hungary SMO
01.2001 - 01.2004

study assistant and co-ordinator

Diagnostic Units Hungary SMO
01.1999 - 01.2001

assistant, Department of Cardiology and ICU

Haynal Imre University of Health Sciences
01.1996 - 01.1999

Healthcare Manager - Healthcare management

Semmelweis University
09/2000 - 08/2002

Bachelor of Science - Faculty of Health Sciences

Haynal Imre University of Health Sciences
09/1995 - 06/1999

Secondary School -

Táncsics Mihály Secondary School
09/1991 - 06/1995
Attila Kiss