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Work Background
Viacrystal LtdClinical Operations Manager
Oct. 2024 - May. 2025Budapest, Hungary1.Operational Team Management: Oversee the performance of operational teams.
Ensure effective management at both regional and local levels. 2. Human Resources: Source and interview new candidates.
Monitor current resources to ensure even workload distribution. 3. Line Management: Conduct regular one-on-one meetings with employees.
Report status updates to the CEO.
Create and present individual training plans. 4. Quality Management: 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. 5. Finance: 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. 6. Client and External Relations: 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. www.viacrystal.com
ICON plcSenior Site Management Associate
Apr. 2023 - Oct. 2024Budapest, HungaryAssists 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, fa ciliate 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)
Performs 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
ICON plcSite Management Associate II
Apr. 2022 - Mar. 2023Hungary
PRA Health SciencesIn-House CRA II
Apr. 2021 - Jul. 2022Assists in the creation and maintenance of clinical project documents including, but not limited to Clinical Management
Plans, monitoring Guidelines, Site Operations Manuals, Monitoring Visit Letter templates and Project Start-up Plans under the guidance of the SUL/CTM.
Supports the CTM/SUL/CRA to resolve internal and external clinical issues for client research projects managed by PRA.
Interacts with site, clients, vendors and PRA functional areas as secondary project contact for site issues and question
Supports CTM/SUL/CRA in the management of clinical budget and evaluation of study processes. Evaluates metric data to identify process improvements.
Assists with managing and training staff.
Manages time and project requirements based on study contract
Liaises with internal and external customers to meet project specific goals including participation in sponsor and project
related meetings
Acts as a liaison with clinical supply/service vendors and other functional area team members to meet project team
goals.
Identifies, monitors, documents, and tracks out-of-scope activities.
Supports Clinical Team Manager (CTM)/Start Up Lead (SUL) and Clinical Research Associate (CRA)
in the management
of investigational sites to ensure compliance with study timelines, the trial protocol, ICH/GCP and applicable regulations.
Assists with Investigational Product accountability, subject screening/enrollment, Case Report form retrieval and query
distribution to/from investigational sites.
Proficient in the development and review of Informed Consent Form templates.
May serve as an Independent Essential Document Reviewer and/or perform second review of Essential
Documents
ICON plcGlobal CTA
Nov. 2018 - Apr. 2021Hungary-Providing general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s). • Assisting the Clinical Operations teams in completion of all required tasks to meet departmental and project goals. • Supporting 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. • Assisting 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. • Processing 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
KCRClinical Trial Documentation Associate and Office Manager
Oct. 2016 - Nov. 2018HungaryCTDA responsibilities
- Being responsible for all administrative aspects of ongoing clinical study, cooperating with CRAs
- Translating study-related documents
- Managing Trial Master File and preparing Investigator’s Files
- Participating in feasibility process (contacting potential sites, collecting questionnaires)
- Participating in teleconferences with Sponsor and Study Team
- Preparing submission to Competent Authority and Ethic Committees
- Participating in process of preparation of ISF and TMF to sponsor audit
- Participating in Investigators Meetings
- Participating in monitoring visit with CRA - Preparing payments tracker and taking care of invoices
- Participating in process of preparing contracts with sites
- Participating in contract negotiation process
- Taking care of eTMF set up
- Performing high-level QC of eTMF documentation
- Informing Line Manager regularly about study and eTMF status Office Manager responsibilities: - Ordering office stationary
- Ordering food vouchers
- taking care of office invoices - taking care of new employees (entrance process documentation)
- dealing with vendors(office equipment, car leasing, mobile, internet, office rent, bank cards, medical check up etc.)
- organizing office team meetings, preparing meeting minutes
- handling and solving ad-hoc office related issues
- organizing meetings for KCR/Sponsor (+accommodation, taxi)
PRA InternationalProject Manager-EDS-PPS
Jan. 2014 - Aug. 2016Hungary, Budapest- 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
CovanceStudy Start Up Assistant
Nov. 2011 - Jan. 2014Hungary, Budapest- Assisted in Feasibility (document sending and collection)
- Prepared the site documents for PSV
- Collected documents for RA/EC submission
- Prepared country specific adaptation of English PIS/ICF and verified Hungarian PIS/ICF ’s translation
- Performed country specific adaptation of other patient related documents (Patient Card, IMP label etc.) and verified the Hungarian patient related document’s translation - Performed country specific adaptation of contracts
- Prepared Site specific contracts
- Performed contract and budget negotiation
- Prepared IMP checklists and collected essential documents to get green light for the SIV - Updated Trial Tracker/CTMS /eTMF
- Conducted follow-up calls/telephone interviews with Investigators/Study Coordinators
ICON Clinical ResearchCTA (Clinical Trial Assistant)
Feb. 2010 - Oct. 2011Hungary- Prepared study files (Monitoring Files, Site Files, Patient binders, Trial Master Files)
- Managed and maintained study files and documentation ensuring high levels of accuracy
- Updated study documentation and tracked trial progress
- Recorded dispatch of study supplies
- Arranged and attended internal and external meetings, and supported preparation of presentation materials
- Attended on Teleconferences and generated meeting minutes
- Contacted external and internal individuals to collate relevant study information - Performed any other duties delegated by CRA or Line Manager
ICON Clinical ResearchReceptionist
Sep. 2008 - Jan. 2010Hungary, Budapest- Answered all incoming calls
- Distributed and handled all incoming and outgoing posts
- Managed and distributed incoming faxes
- Assisted with general administrative duties
- Ordered office stationary regularly
- Contacted with courier companies and prepare packages
- Maintained relationship with vendors
Mega Outdoor Media KftAdministrator, sales assistant
Mar. 2008 - Aug. 2008Built networks and supported the activities of the sales team
OTP Garancia Biztosító Zrt.insurance assistant
May. 2006 - Mar. 2008-Settled of pending and advance items
-Maintained relationship with business centers, administrative duties related to the bookkeeping of fees
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