Summary
Overview
Work History
Education
Skills
Skills
Training History
Therapeutic Aeras
Languages
Websites
Timeline
Generic
Gabriella Sipkayné Miterli

Gabriella Sipkayné Miterli

Remeteszőlős

Summary

I am a passionate and results-driven clinical research professional with over 16 years of experience in clinical trials. I enthusiastically oversee financial matters, maintains client and vendor relations, skillfully take part in study procedures, actively supervising processes and maintaining SOPs, organizations can pre-emptively address discrepancies that might arise during audits. With a strong work ethic, excellent communication skills, and proven problem-solving abilities, I am eager to monitor balanced allocation of work, preventing burnout and enhancing job satisfaction among employees. Quality-focused healthcare professional with several years' hands-on experience in clinical administration and patient care, advocacy and counseling. Talented at developing and actualizing strategies which streamline workflows and improve quality standards. Proven effective at guiding multi-disciplined healthcare teams to succeed in achieving patient outcome goals.

Overview

17
17
years of professional experience

Work History

Clinical Operations Manager

Viacrystal Ltd
10.2024 - Current
  • Oversee the performance of operational teams.
  • Ensure effective management at both regional and local levels.
  • Source and interview new candidates.
  • Monitor current resources to ensure even workload distribution.
  • Conduct regular one-on-one meetings with employees.
  • Report status updates to the CEO.
  • Create and present individual training plans.
  • Continuously monitor quality to ensure audit readiness.
  • Review and verify CVs and GCP exams annually.
  • Keep company SOPs up to date.
  • Represent operational leadership during sponsor and internal audits.
  • Separate billable and non-billable items and forward accurate information to accounting.
  • Manage feasibility and participate in the initial client request process.
  • Support the feasibility process.
  • Prepare representations for clients and sites.
  • Oversee depo activities and coordinate overall depo operations.
  • This role is pivotal in ensuring the smooth operation and high-quality standards of clinical operations, making it essential for the success of the organization.

Site Management Associate

ICON Clinical Research(Formerly PRA Health Sciences)
04.2021 - 10.2024
  • Assists in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating and reviewing responses to site recruitment questionnaires.
  • Completes essential document collection and review throughout the study lifecycle inclusive of site activation.
  • Organizes and maintains site clinical trial master file (TMF) documents.
  • Sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines.
  • Acts as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies and conducting offsite central monitoring visits/contacts (pre-study, initiation, monitoring and close out visits). Escalates issues and risks as needed.
  • Ensure timely and complete data entry by site.
  • Perform data review inclusive of site level data review, query resolution, facilitate database closure and freezing procedures as per study plans.
  • Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.
  • Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements.
  • Performs recruitment of study sites, ensuring activities, documents and all other clinical data are accurately tracked and documented for the project lifecycle. Escalates issues as needed.
  • May serve as a patient management associate (conduct patient interviews, answer questions, follow up on issues).
  • Perform and documents clinical data review and query creation, query resolution, offsite central monitoring contacts/visits.
  • Sets up and maintains study documentation in applicable systems(CTMS, TMF) applicable site/sponsor systems according to project protocol, applicable SOPs and project plans.
  • Mentoring new SMAs.
  • Involved in payment issue resolutions.

Global Clinical Trial Assistant

ICON Clinical Research
09.2018 - 04.2021
  • Provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).
  • Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
  • Support the Clinical Operations teams with ongoing conduct of studies.
  • To be familiar with ICH GCP, appropriate regulations, relevant ICON SOP's and ICON internal tracking systems.
  • To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.
  • Assist project teams with study specific documentation and guidelines as appropriate.
  • Setting up and maintaining clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
  • Process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.
  • To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
  • To co-ordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies).
  • Play a key role in successful global study delivery, providing subject matter expertise across key processes and systems through the live cycle of the study.
  • Work in collaboration with the Global PMs to provide end to end operational and administrative support for study delivery activities in your assigned trials.
  • Responsible for setting up and maintaining systems and tracking tools that ensure quality, consistency and integration of study data, following up on discrepancies if needed.
  • Granting access to new system users.
  • Completion and maintenance of internal systems/databases/tracking tools and project plans.
  • Supporting the study team in global study coordination activities.
  • Development and review of study documents and study plans.
  • Vendor Management.
  • Country Oversight.
  • Risk Management.
  • Clinical Supplies oversight and recruitment materials management.

Clinical Trial Assistant and Office Manager

KCR CRO
10.2016 - 09.2018
  • Being responsible for all administrative aspects of ongoing clinical study, cooperating with CRAs.
  • Translate study-related documents.
  • Manage Trial Master File and preparing Investigator's Files.
  • Participate in feasibility process (contacting potential sites, collecting questionnaires).
  • Participate in teleconferences with Sponsor and Study Team.
  • Prepare submission to Competent Authority and Ethic Committees.
  • Participate in process of preparation of ISF and TMF to sponsor audit.
  • Participate in Investigators Meetings.
  • Participate in monitoring visit with CRA.
  • Prepare payments tracker and taking care of invoices.
  • Participate in process of preparing contracts with sites.
  • Participating in contract negotiation process.
  • Take care of eTMF set up.
  • Perform high-level QC of eTMF documentation.
  • Inform Line Manager regularly about study and eTMF status.
  • Order office stationary.
  • Order food vouchers.
  • Take care of office invoices.
  • Take care of new employees (entrance process documentation).
  • Dealing with vendors (office equipment, car leasing, mobile, internet, office rent, bank cards, medical check up etc.).
  • Organize office team meetings, preparing meeting minutes.
  • Handle and solving ad-hoc office related issues.
  • Organize meetings for KCR/Sponsor (+accommodation, taxi).

Project Manager -Early Phase studies

PRA Health Sciences
01.2013 - 10.2016
  • Oversaw the progress of a clinical trial.
  • Ensured that the study is conducted, recorded and reported in accordance with the protocol, SOPs, GCP, local regulations, regulatory requirements.
  • Prepared regular study status report for Project Director.
  • Examined whether organizational timeframes for local research activities were appropriate, that internal standards and ICH-GCP requirements were met.
  • Ensured that facilities and equipment checks were done regularly and documented appropriately.
  • Reviewed and supported study document preparation (e.g. Protocol, PIS/ICF, study related guidelines).
  • Prepared country specific regulatory documents (PIS/ICF).
  • Prepared submission packages and submitted them to local RA/EC.
  • Informed and trained site staff about the Protocol Amendments and ensured the trainings for the new study related procedures have been performed and documented.
  • Escalated study related issues immediately to local Project director and Global Study Director.
  • Ensured that SOPs were implement for all local research activities to conduct regular site file QC checks.
  • Participated in Site Selection Visits, IMs, SIVs, COVS.
  • Ensured that the payments are done regularly.

Study Start Up Associate

LabCorp (Formerly Covance Inc.)
11.2011 - 01.2013
  • Assist in Feasibility (document sending and collection).
  • Prepare the site documents for PSV.
  • Collect documents for RA/EC submission.
  • Prepare country specific adaptation of English PIS/ICF and verified Hungarian PIS/ICF 's translation.
  • Perform country specific adaptation of other patient related documents (Patient Card, IMP label etc.) and verified the Hungarian patient related document's translation.
  • Perform country specific adaptation of contracts.
  • Prepare Site specific contracts.
  • Perform contract and budget negotiation.
  • Prepare IMP checklists and collected essential documents to get green light for the SIV.
  • Update Trial Tracker/CTMS/eTMF.
  • Conduct follow-up calls/telephone interviews with Investigators/Study Coordinators.

Clinical Trial Assistant

ICON Clinical Research
02.2010 - 11.2011
  • Prepare study files (Monitoring Files, Site Files, Patient binders, Trial Master Files).
  • Manage and maintained study files and documentation ensuring high levels of accuracy.
  • Update study documentation and tracked trial progress.
  • Record dispatch of study supplies.
  • Arrange and attended internal and external meetings, and supported preparation of presentation materials.
  • Attend on Teleconferences and generated meeting minutes.
  • Contact external and internal individuals to collate relevant study information.
  • Perform any other duties delegated by CRA or Line Manager.

Receptionist, Facility Support

ICON Clinical Research
09.2008 - 02.2010
  • Answer all incoming calls.
  • Distribute and handled all incoming and outgoing posts.
  • Manage and distributed incoming faxes.
  • Assist with general administrative duties.
  • Order office stationary regularly.
  • Contact with courier companies and prepare packages.
  • Maintain relationship with vendors.

Education

Healthcare Management -

Sopron University
Sopron, Hungary
01.2022

Economics, Marketing Management -

Budapest Business School
Budapest, Hungary
01.2014

Skills

  • MS applications
  • EDC Systems
  • IWRS Systems
  • TMF Systems
  • CTMS
  • Clinical trial management
  • Regulatory compliance
  • Quality assurance
  • Data management
  • Operational oversight
  • Project management
  • Team leadership
  • Risk assessment
  • Vendor management
  • Budget management
  • Feasibility assessment

Skills

native, proficiency, basic, basic, MS applications proficiency, EDC Systems (RAVE, InForm, Bioclinica) proficiency, IWRS Systems (Clario, Suvoda, Yprime) proficiency, TMF Systems (Oracle, Veeva, Phlex) proficiency, CTMS (Siebel, PSO etc) proficiency

Training History

  • 10/01/24, GCP exam-NIDA
  • 04/01/24, GCP- Yearly Refresher (ICON PLC Formerly PRA Health Sciences)
  • 04/01/23, GCP- Yearly Refresher (ICON PLC Formerly PRA Health Sciences)
  • 06/01/22, SMA Mentor training (ICON PLC Formerly PRA Health Sciences)
  • 04/01/22, GCP- Yearly Refresher (ICON PLC- Formerly PRA Health Sciences)
  • 04/01/21, GCP- (ICON PLC- Formerly PRA Health Sciences)
  • 09/01/20, GCP- Yearly Refresher (ICON PLC)
  • 09/01/19, GCP- Refreshment training (ICON PLC)
  • 09/01/18, GCP- (ICON PLC)
  • 12/01/14, GCP-Debreceni Orvostudományi Egyetem

Therapeutic Aeras

  • NASH, Hepatology, III, Site Management Associate, 2021, 2024
  • Lung Cancer, Oncology, III, Site Management Associate, 2021, 2024
  • Muscle-Invasive Urothelial Carcinoma, Oncology, III, Site Management Associate, 2022, 2024
  • Alzheimer's disease, Neurology, III, Site Management Associate, 2021, 2024
  • Crohn's disease, Gastroenterology, III, Site Management Associate, 2021, 2023
  • Nucleophosmin 1-mutated Acute Myeloid Leukemia, Oncology, III, Site Management Associate, 2021, 2022
  • Immune thrombocytopenic purpura, Immunology, I/II, Site Management Associate, 2021, 2022
  • Sick Cell disease, III, Site Management Associate, 2021, 2022
  • Inflammation, Oncology, III, Global Clinical Trial Assistant, 2018, 2021
  • Metastatic Pancreatic Ductal Adenocarcinoma, Oncology, I/II, Global Clinical Trial Assistant, 2018, 2021
  • Non-small Cell Lung Cancer, Oncology, Ib, Global Clinical Trial Assistant, 2018, 2021
  • Restless Leg Syndrome, Neurology, III, Clinical Trial Assistant, 2016, 2018
  • Post-operative acute pain, Surgery, III, Clinical Trial Assistant, 2016, 2018
  • Hemostatic Treatment During Parenchymous Tissue Open Surgeries, Hematology, III, Clinical Trial Assistant, 2016, 2018
  • Influenza Vaccine, Vaccine, Immunology, III, Clinical Trial Assistant, 2016, 2018
  • Chronic Renal Failure, Nephrology, II, Project Manager, Early Phase Development, 2013, 2015
  • Chronic Renal Failure, Nephrology, I, Project Manager, Early Phase Development, 2013, 2015
  • Rheumatoid Arthritis, Rheumatology, I, Project Manager, Early Phase Development, 2013, 2015
  • Pancreatic Cancer, Oncology, II, Project Manager, Early Phase Development, 2013, 2015
  • BRAF Mutation, Oncology, I, Project Manager, Early Phase Development, 2013, 2015
  • Rheumatoid Arthritis, Rheumatology, II, Study Start Up Associate, 2011, 2013
  • Asthma, Pulmonology, III, Study Start Up Associate, 2011, 2013
  • Glioblastoma, Oncology, III, Study Start Up Associate, 2011, 2013
  • Breast Cancer, Oncology, III, Study Start Up Associate, 2011, 2013
  • Squamous cell carcinoma head and neck metastasis, Oncology, III, Study Start Up Associate, 2011, 2013
  • Hypercholesterolemia, Cardiology, III, Study Start Up Associate, 2011, 2013
  • Ulcerative Colitis, Immunology, III, Study Start Up Associate, 2011, 2013
  • Acute myocardial infarction, Cardiology, III, Study Start Up Associate, 2011, 2013
  • Tourette Syndrome, Neurology, III, Study Start Up Associate, 2011, 2013
  • Diabetic Kidney Disease, Diabetology, III, Clinical Trial Assistant, 2010, 2011
  • Acute Coronary Syndrome, Cardiology, III, Clinical Trial Assistant, 2010, 2011
  • Prostate Cancer, Oncology, III, Clinical Trial Assistant, 2010, 2011

Languages

Hungarian
First Language
English
Advanced (C1)
C1
Swedish
Beginner
A1
Italian
Beginner
A1

Timeline

Clinical Operations Manager

Viacrystal Ltd
10.2024 - Current

Site Management Associate

ICON Clinical Research(Formerly PRA Health Sciences)
04.2021 - 10.2024

Global Clinical Trial Assistant

ICON Clinical Research
09.2018 - 04.2021

Clinical Trial Assistant and Office Manager

KCR CRO
10.2016 - 09.2018

Project Manager -Early Phase studies

PRA Health Sciences
01.2013 - 10.2016

Study Start Up Associate

LabCorp (Formerly Covance Inc.)
11.2011 - 01.2013

Clinical Trial Assistant

ICON Clinical Research
02.2010 - 11.2011

Receptionist, Facility Support

ICON Clinical Research
09.2008 - 02.2010

Healthcare Management -

Sopron University

Economics, Marketing Management -

Budapest Business School

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Gabriella Sipkayné Miterli