Clinical Research Project Manager

vor 3 Wochen

Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit

The Clinical Functional Service Partnerships (Clinical FSP) department at IQVIA is supporting a client's project team in the execution of clinical trials. This role provides the opportunity to work with a single client and manage clinical research projects in various therapeutic areas.

We are seeking a Local Trial Manager to join our team in full-time and work home-based throughout Germany, preferably in the North Rhine-Westphalia area.

Responsibilities

  • Ensure services adhere to applicable company standard operating procedures (SOPs), work instructions, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
  • Prepare or contribute to high-level budget estimates in response to Request for Services, followed by detailed budget proposals. Ensure overall contract management, including review and approval of external service provider (ESP) contracts, change orders, and ensure services are delivered per contract.
  • Act as the primary company contact for assigned trials at the country level and ensure local/country teams track project progress against planned timelines and monitor patient recruitment rates to ensure target enrollment is met across allocated countries.
  • Drive study compliance by maintaining and updating trial management systems, using study tools, and management reports available to analyze trial progress. Participate in preparation for and conduct of Health Authority (HA) 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.
  • Deliver competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection.
  • Contribute to patient understanding of protocol and patient safety by contributing to the review of country-specific informed consent in accordance with procedural documents/templates.
  • Ensure trial subject safety by reporting all AEs/SAEs/PQCs within required reporting timelines and documenting, as appropriate.
  • Ensure inspection readiness by maintaining complete, accurate, and timely data and essential documents in systems utilized 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 CAPA is implemented for audits/inspections or any quality-related issues or concerns.
  • Ensure accurate finance reporting and trials delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budgets. If applicable, may assist in negotiation of trial site contracts and budgets.
  • Keep trials in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
  • May contribute as a mentor, champion, or representative of functional areas in process initiatives, as required and if applicable.

Required Knowledge, Skills, and Experience

  • Bachelor's or higher-level degree preferable in life science.
  • Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO, plus preferable 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).

We invite you to join IQVIA.

Please apply with your English CV, motivation letter, and your certificates and reference letters.

#LI-KA1

IQVIA 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 at

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