Clinical Project Manager

With over 15 years in clinical research, including early phase studies, they excel in global clinical operations to ensure compliance and successful trial outcomes. They are hands-on while able to lead cross-functional teams.

Certified GCP Clinical Site Auditor with expertise in global clinical project management; they enhance trial efficiency through innovative design and operational excellence.

Proficient in managing complex clinical trials; they have a proven track record in protocol development, risk assessment, and regulatory compliance across multiple therapeutic areas.

Fluent in English, German, and Hungarian, they leverage their multilingual skills to facilitate international collaborations and ensure high-quality clinical outcomes.

Clinical Trial Oversight and Management: Ensure compliance with GCP, SOPs, and regulations, manage recruitment across countries, and collaborate with LCRA to align the monitoring team with trial needs

Timeline and Resource Planning: Coordinate trial timelines with the CTL, plan resources like Veeva eTMF and co-monitoring, and ensure on-time trial execution and activity completion

CRO and Vendor Management: Oversee and evaluate CRO and service provider performance using KPIs, collaborate with the Vendor Management team, and assist in vendor selection and management

Document and Risk Management: Lead the creation and approval of essential trial documents, manage risk identification and mitigation, and track audit findings and CAPAs

Data Review and Reporting: Participate in ongoing and final data reviews, reporting issues or trends to the CTL

Team Leadership and Communication: Lead team meetings, provide training and mentorship to team members, and ensure effective communication between the sponsor, CRO, and other stakeholders

Planning & conducting of two vaccines Prospective Study in accordance with GCP/ICH guidelines and EU regulations

Identifying, assessing, and mitigating risks associated with study conduct, from start to close-out

Preparation, review, and approval of all relevant study documents in collaboration with external service

Contract negotiations with external service providers (CROs, central laboratories)

Planning and monitoring the study budget and timelines

Scientific evaluation and summarization of study results in the form of conference papers and scientific publications

Processing of official enquiries regarding clinical authorization studies

Vendor management oversight

Planning, conducting and analyzing international epidemiological and clinical approval studies of phases IIV in accordance with GCP/ICH guidelines and EU regulations

Developing comprehensive operational study designs tailored to meet both scientific and business objectives.

Identifying, assessing, and mitigating risks associated with study conduct, from start to close-out

Preparation, review and approval of all relevant study documents in collaboration with external service providers

Contract negotiations with external service providers (CROs, central laboratories)

Planning and monitoring the study budget and timelines

Organization and implementation of investigator meetings

Scientific evaluation and summarization of study results in the form of conference papers and scientific publications

Processing of official enquiries regarding clinical authorization studies

Vendor management oversight

Oversees all other functional staff in order to adhere to and deliver committed timelines

All clinical operational aspects pertaining to planning, start-up and management of assigned clinical Phases I and III trial

Identification, selection, and management of external service providers and CROs

Co-development and review of study documents eg. study protocol, informed consent form, monitoring guidelines, Case Report Forms, regulatory authority submissions

Oversight and regular reporting of study progress to ensure completion within agreed timelines/milestones and budget

Development and control of agreed study budget

Preparation and active contribution in GCP audits

Conduct CRO oversight activities on a regional basis, ensuring sponsored clinical trials are conducted in accordance with ICH/GCP and delivered on time and on budget

Responsible for the review of clinical trial documents including (but not limited to) consent documents, confidentiality agreements, study related plans and Investigator agreements (CTA)s

Responsible for oversight of IRB/EC and RA submissions

Reviewing pre-study, study initiation, interim monitoring visit and study closeout visit reports and ensuring findings are addressed with the CRO and looped back to the wider study team as required

Overseeing investigator performance and adherence to protocol, and proactively addresses conduct issues and enrolment problems

Responsible for oversight and maintenance of the TMF and completeness at the end of the study

Conducting and overseeing data sweep, data cleaning, interim analysis

Ensuring study inspection readiness

Conducting on site compliance and audit visits

Responsible for leading and guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan

Leading CRO contracts negotiations together with the vendor manager

Providing input into and/or developing study-related materials such as Clinical Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, study drug order forms, etc.

Overseeing and tracking patient recruitment and proactively identifies ways to prevent recruitment delays

Ensuring that study Trial Master File is maintained and up to date

Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations

Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns

Facilitating timely availability of investigational product supply on site and ensuring that clinical site accountability records on site are maintained