Regional Clinical Trial Manager

vor 4 Wochen

Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit

The IQVIA Clinical Functional Service Partnerships (Clinical FSP) division is dedicated to supporting our client's project teams in the execution of clinical trials. This role offers the opportunity to work closely with a single client while managing clinical research initiatives across various therapeutic areas.

We are currently seeking a Local Trial Manager (m/w/d) for a full-time position, with the flexibility to work remotely throughout Germany, ideally from the North Rhine-Westphalia region.

KEY RESPONSIBILITIES

  • Ensure that all services comply with the company's standard operating procedures (SOPs), work instructions, policies, and codes of Good Clinical Practice (GCP), as well as local regulatory requirements.
  • Prepare or assist in the development of high-level budget estimates in response to Requests for Service, followed by detailed budget proposals. Oversee contract management, including the review and approval of external service provider (ESP) contracts and change orders, ensuring that services are delivered as per the contract.
  • Serve as the primary company contact for assigned trials at the country level, ensuring that the local team tracks project progress against planned timelines and monitors patient recruitment rates to meet target enrollment across allocated countries.
  • Promote study compliance by maintaining and updating trial management systems, utilizing study tools and management reports to analyze trial progress. Participate in the preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
  • Contribute to the recruitment strategy at the site level and assist in contingency planning and implementation in collaboration with other functional areas to achieve clinical research objectives.
  • Provide effective vendor management at the country level to support the study, including submitting requests for vendor services and assisting in vendor selection.
  • Enhance patient understanding of protocols and ensure patient safety by reviewing country-specific informed consent documents in accordance with procedural templates.
  • Guarantee the safety of trial subjects by ensuring that all Adverse Events (AEs), Serious Adverse Events (SAEs), and Protocol Deviations (PQCs) are reported within required timelines and documented appropriately.
  • Maintain inspection readiness by ensuring complete, accurate, and timely data and essential documents are stored in systems used for trial management (e.g., CTMS and VTMF) according to established metrics and archiving requirements.
  • Focus on quality by collaborating closely with GTL MAO and CPL to ensure Corrective and Preventive Actions (CAPA) are implemented for audits, inspections, or any quality-related issues.
  • Ensure accurate financial reporting and that trials are conducted within budget by adhering to financial reporting deliverables and timelines, including forecasting and proactive management of the local trial budget. If applicable, assist in negotiating trial site contracts and budgets.
  • Maintain compliance with local regulatory requirements by organizing and ensuring approvals from the Institutional Ethics Committee (IEC) and Health Authorities (HA), if necessary.
  • May serve as a mentor, champion, or representative of the functional area in process initiatives, as required and applicable.

REQUIRED QUALIFICATIONS

  • A Bachelor's degree or higher in a relevant life science field.
  • A minimum of 5 years of clinical research experience within the pharmaceutical industry or a Contract Research Organization (CRO), with an additional 2-3 years of clinical trial management experience preferred.
  • Strong understanding of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Proficiency in German at a minimum C1 level and a good command of English, with the ability to communicate effectively in both languages.
  • Strong IT skills in relevant software and company systems, with a willingness to travel as needed for business purposes.
  • Excellent decision-making abilities and strong financial management skills.
  • Flexibility and capability to manage study teams in a virtual environment.
  • Willingness to travel for client meetings and occasional site visits.

We invite you to explore opportunities with IQVIATM.

Please submit your CV, motivation letter, and relevant certificates and reference letters.

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are committed to advancing human science and data science to make a significant impact in creating a healthier world. Learn more at

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