Andrea Kovacs Email & Phone Number

- Experience in field: Cardiology/Heart Failure as global COL (Feb 2024 - Oct 2024)- Experience in field: Dermatology as regional COL (Dec 2022 - Feb 2024)- Provide leadership and direction to project team members- Provide input to project tools, PL project plan, Central File Maintenance Plan- Develop site selection and monitoring plan for the team- Review and provide input into patient recruitment plan and retention plan- Evaluate and identify resourcing needs and continuously monitor over life cycle of large/complex project and/or program- Manage study start-up activities- Early recognition of areas of potential problems and provide input to contingency plans- Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project and/or program.- Oversee maintenance and quality check of Central Files- Identify changes in scope and liaise with Project Leader- Participate in client, investigator and team meetings- Prepare, participate in and follow up on audits / inspections

- Accountable for right subjects and right data to meet all contractual requirements.- Collaborate with Project Leader and Centralized Monitoring Lead to establish an integrated set of plans and be ultimately accountable for results of the clinical team.- Represent clinical delivery with customer.- Produce and distribute status reports for the core project team, other functional groups and senior management.- Ensure appropriate subject recruitment plans are in place; all outreach or digital offerings are explored and deployed in consultation with the customer.- Manage clinical study set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress. Report progress to appropriate clinical management and project management forums.- Provide ongoing training and support to the clinical team. Conduct frequent team meetings and ensure regular communication.- Drive high performance and efficiency of the clinical team.- Experience in field: Oncology, being responsible for clinical results of 6 participating countries (regional Clinical Lead, Mar2021-Nov2022)

- Accountable for right subjects and right data to meet all contractual requirements. Collaborate with project leader and CML to establish an integrated set of plans and be ultimately accountable for results of the Clinical team.- Represent clinical delivery with customer.- Produce and distribute status reports for the core project team, other functional groups and senior management.- Ensure appropriate subject recruitment plans are in place; all outreach or digital offerings are explored and deployed in consultation with the customer.- Manage clinical study set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress. Report progress to appropriate clinical management and project management forums.- Provide ongoing training and support to the clinical team. Conduct frequent team meetings and ensure regular communication.- Drive high performance and efficiency of the clinical team.- Experience in field: Oncology

Site management support by leading team of 5 CRAs:• Ensuring that study requirements and project milestones are met• Participating in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training• Responsibilities include planning, assigning, and directing work; motivating and engaging CRAs; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters• Conducting onboarding training for new staff

Hungary

- Perform Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule- Perform monitoring visits in accordance with the monitoring plan- Perform site visits in accordance with ICH-GCP and IQVIA SOP's- Conduct remote visits in DTE studies- Monitor patient safety on an ongoing basis and evaluate the overall compliance and performance of sites- Review patient enrollment- Have Lead CRA responsibilities in all allocated studies- Experience is fields: Cardiology, Oncology

Hungary

- Performing Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule- Performing monitoring visits in accordance with the monitoring plan- Performing site visits in accordance with ICH-GCP and IQVIA SOP's- Conducting remote visits in DTE studies- Monitoring patient safety on an ongoing basis and evaluate the overall compliance and performance of sites- Reviewing patient enrollment- Having Lead CRA responsibilities in all allocated studies- Experience is fields: Cardiology, Oncology

Budapest

- Performing monitoring visit at investigational site- Reviewing patient enrollment- Ensuring that investigators follow the proper clinical trial protocol

Budapest

- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.- Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. - Assist with periodic review of study files for completeness.- Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.

Debrecen

- Supporting packaging process of TEVA products- Translating documents in the Active Pharmaceutical Ingridients department- Gaining experience in the detailed processes of a multinational company in the pharmaceutical industry

Debrecen

- Supporting eximination of relevant clinical cases in connection with genetic disorders (e.g. cystic fibrosis)- Administrative tasks- PCR analysis- Agarose gelelectrophoresis- DNA Sequence analysis

Master'S Degree, Molecular Biology

Bachelor'S Degree, Medical Laboratorial Diagnostic Imaging Analysis

High School