Clinical Research Manager in Germany
vor 1 Monat
Are you a seasoned professional looking for a challenging role in clinical research?
We are seeking an experienced Clinical Trial Manager to join our team at IQVIA, working full-time from home based throughout Germany, preferably in the North Rhine-Westphalia area.
This is an exciting opportunity to lead and manage clinical research projects in different therapeutic areas. As a Clinical Trial Manager, you will be responsible for ensuring that all clinical trials are conducted in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines.
Key Responsibilities:- Develop and execute high-level budget estimates in response to Request for Services, followed by detailed budget proposals, ensuring overall contract management, including review and approval of external service provider contracts, change orders, and ensure services are delivered per contract.
- Serve as the primary company contact for assigned trials at the country level, ensuring local/country teams track project progress against planned timelines and monitor patient recruitment rates to meet target enrollment across allocated countries.
- Drive study compliance by maintaining and updating trial management systems, using study tools, and management reports to analyze trial progress, participating in preparation for and conduct of Health Authority inspections and internal Quality Assurance audits.
- Contribute to site-level recruitment strategies and contingency planning and implementation in partnership with other functional areas to achieve clinical research targets.
- Demonstrate competent vendor management at the country level to support studies, submitting requests for vendor services and supporting vendor selection.
- Contribute to patient understanding of protocols and patient safety by reviewing country-specific informed consent in accordance with procedural documents/templates.
- E nsure trial subject safety by reporting all Adverse Events (AEs), Serious Adverse Events (SAEs), and Product Quality Complaints (PQCs) within required reporting timelines and documenting them as appropriate.
- E nsure inspection readiness by maintaining complete, accurate, and timely data and essential documents in systems used for trial management (e.g., CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.
- Work closely with GTL MAO, CPL to ensure Corrective Action Preventive Actions (CAPA) are implemented for audits/inspections or quality-related issues/concerns.
- E nsure accurate finance reporting and trial delivery within budget by adhering to finance reporting deliverables and timelines, including forecasting and proactive management of country/local trial budgets. If applicable, assist in negotiation of trial site contracts and budgets.
- E nsure compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
- Bachelor's or higher-level degree preferable in life sciences.
- Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO, plus preferred 2-3 years of clinical trial management experience.
- Strong working knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Fluent language skills in German on at least C1 level and good command of English. Proficient in speaking and writing in both languages.
- Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stays away from home according to business needs.
- Excellent decision-making and strong financial management skills.
- Flexibility and ability to manage study teams in a virtual environment.
- Flexibility to business travel (client meetings and occasional site visits).
The estimated salary for this position is approximately €80,000 - €100,000 per year, depending on qualifications and experience.
About IQVIAIQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more about us at https://www.iqvia.com/.
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