Local Trial Manager - Sponsor Dedicated
iqvia · Prague
Job description
About the role
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department supports its client's project team in executing clinical trials. As a Local Trial Manager (full-time) in the Czech Republic, you will work with one single client and manage clinical research projects across different therapeutic areas.
Key responsibilities
- Prepare or contribute to high-level budget estimates and detailed budget proposals, forecast the country/local trial budget and ensure accurate finance reporting within budget.
- Manage the contract, including review and approval of external service provider contracts and change orders, and deliver competent vendor management at country level.
- Act as the primary company contact for the assigned trial at country level, tracking progress against timelines and monitoring patient recruitment rates.
- Maintain and update trial management systems, prepare for and take part in Health Authority inspections and internal quality assurance audits, and implement CAPAs for quality issues.
- Contribute to site-level recruitment strategy, patient understanding of the protocol, informed consent review and subject safety reporting of AEs/SAEs/PQCs.
- Ensure inspection readiness by keeping data and documents complete, accurate and timely in systems such as CTMS and VTMF, and obtain IEC/HA approvals where applicable.
- Work with the Global Trial Lead and Clinical Project Lead, and may mentor, champion or represent the function in process initiatives.
Required profile
- Master's or higher-level degree in life sciences.
- At least 5 years of clinical research experience in the pharmaceutical industry or CRO, plus 1-3 years of local clinical trial management experience.
- Fluent Czech at C1 level and good command of English; willingness to travel occasionally for business meetings.
- Preferred: therapeutic area expertise in oncology or haematology.
Required skills
- Strong knowledge of GCP and ICH guidelines and local regulatory requirements.
- Strong IT skills in clinical research software and company systems.
- Excellent decision-making and financial management skills; ability to manage study teams virtually.
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iqvia
Prague