Klara Geiger has over 15 years of experience managing clinical trial contracts and payments. She currently works as a Start-Up Specialist Contracting SPOC at Quintiles Ltd, where she serves as a single point of contact for sites and ensures adherence to procedures and timelines. Previously, she worked at Amgen Ltd as a Senior Associate for Clinical Contracts and Budgets, negotiating site contracts and budgets. She also has experience in regulatory affairs from her time at Gedeon Richter Plc. Klara has strong administration, communication, and problem-solving skills and expertise in clinical systems and regulations.

1. KLARA GEIGER+36-30-459-8917 1 / 3
Geiger Klára
+36-30-459-8917
geiger.klara@gmail.com
Experiences
6.5 years in managing clinical trial contracts and payments
 07/2015 – present: Start-Up Specialist Contracting SPOC
Quintiles Ltd.
o Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for
investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project
Management and CST
o Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of
designated deliverables and to project timelines
o Perform Contracting and Maintenance activities according to applicable regulations, SOPs and
work instructions
o Distribute completed documents to sites and internal project team members
o Review, prepare and negotiate site contracts and budgets with sites
o Ensure accurate completion and maintenance of internal systems, databases and tracking
tools with project specific information
o Review and provide feedback to management on site performance metrics
o Review, establish and agree on project planning and project timelines. Ensure monitoring
measures are in place and implement contingency plan as needed
o Inform team members of completion of contractual documents for individual sites
o Review, track and follow up the progress, the approval and execution of documents, including
contracts and IP Release documents, in line with project timelines
o Provide local expertise to RSU leads and Project team during initial and on-going project
timelines planning
o Perform quality control of documents provided by sites
o Have direct contact with sponsors on specific initiatives
including 1 year as Maintenance Lead
o Managing and supervising a group of 2-7 people
 09/2012-06/2015 – Maternity leave
 01/2008 – 06/2015: Senior Associate Clinical Contracts and Budgets
Amgen Ltd.
o Up to date knowledge of legal compliances;
o Act as liaison between Company staff and external contacts, inform the Company’s Legal
Department from any changes of local regulations and manage to harmonize with approved
templates;
o Act in site initialization, contact daily with study team and management;

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o Provide site and vendor contracting support services;
o Contact with members of the sites to collect and control contracting data;
o Provide help to members of the sites in connection with contract, payment and administration
issues;
o Develop draft study and study related contracts consistent with the Company and local legal
requirements, client expectations and approved templates;
o Review forms and contents of contracts;
o Manage, track, follow up on and report on status of documents relating to study agreements
with clinical research sites globally, to ensure contracts are electronically stored, indexed and,
whenever possible, searchable;
o Ensure to process execute contracts and other, study related documents in timely manner;
o Manage to amend contracts according to change of site budget or request of vendor;
o Review, prepare and draft site budget according to the protocol and local requirements;
o Ensure timely and accurate payments per terms and conditions of executed contracts, review
the contents and forms of invoices accordingly; shipping invoices to Financial Department and
tracking transfers;
o Using SAP, entering vendors to the system, generating PO numbers;
o Collaboration with Company’s other contract specialists from different locations to harmonize
global processes;
o Act in provide documentation for audits
including 3 years as Mentor and Trainee
o Mentoring new staff members, giving frequent legal and contract process training
3 years in regulatory affairs
 03/2005 – 12/2007: Regulatory Affairs – Richter Gedeon Plc.
o International licensing in countries, outside Europe;
o Renewal licenses for countries within Europe;
o Contact with partners and the License Authorities;
o Daily contact and collaboration with Departments within the Company for ensure to process
necessarily documents in timely manner;
o Up to date knowledge of license regulations and requirements;
o Daily use of document management system;
o Compilation of documents for electronic submissions
12/2001 – 12/2005: Maternity leave
1 year in laboratory assistant
 09/2000 – 06/2001: Laboratory Assistant – Bábolna Bio Ltd.
o Product developing: pesticides, household chemicals;
o in vitro experimentations with hormone analogues
Main skills
 Work precisely, excellent administration skills
 Strong interpersonal and communication skills
 Excellent problem solving
 Pro-activity
 Ability to prioritize and meet deadlines while working on multiple projects
 In-depth knowledge of clinical systems, procedures

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 Ability to work independently, and to effectively prioritize tasks
 Good team worker
 Ability to manage multiple projects
 Knowledge and ability to apply GCP/ICH and applicable guidelines
 Understanding of regulated clinical trial environment and knowledge of drug development
process
 Ability to establish and maintain effective working relationships with coworkers, managers
and clients.
Certification
GCP (November 2016)
Global Projects
 Act in executing Global Business Process Restructuring, establishing a new business unit,
giving training and managing knowledge transfer
 Super user of a new Global Document and Workflow Management System
 Act in developing a global payment system;
 Act in testing an uniform contract generating system;
 Harmonize the global contracts templates with local requirements;
 Act in testing regulatory document management system
Workplaces
Quintiles Hungary Ltd. (2015 - present)
Maternity leave (2012-2015)
AMGEN Ltd. (2008 - 2015)
Gedeon Richter Plc. Hungary (2005 - 2007)
Maternity leave (2001-2004)
Bábolna Bio Ltd. (2000-2001)
Educations
Public procurement rapporteur course - EFEB Ltd. (2015)
MSc. Law specialist engineer- Eötvös Loránd University Legal Professions and Studies (2006)
MSc. Environmental Management – Szent István University, Gödöllő (2001)
MSc. Social Science- Szent István University, Gödöllő (2001)
Matriculation – Fáy András Agricultural Secondary School (1994)
Languages
English: C type intermediate (general)
German: basic knowledge
PC skills
MS Office: proficient knowledge in Word, Excel and Outlook, MS Sharepoint
Driver’s license
B category