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Clinical Research Manager

vor 2 Monaten


Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit

Job Summary

IQVIA is seeking a highly skilled Clinical Research Manager to join our team in Germany. As a key member of our Clinical Functional Service Partnerships (Clinical FSP) department, you will play a critical role in supporting our client's project team in the execution of clinical trials.

Key Responsibilities

  • Ensure that all services rendered 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 Requests for Service, 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 are tracking project progress against planned timelines and monitor patient recruitment rates to ensure target enrollment will be 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 Adverse Events (AEs)/Serious Adverse Events (SAEs)/Protocol Violations (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 Global Trial Lead (GTL) Management, Clinical Project Lead (CPL) to ensure Corrective Action Preventive Action (CAPA) is implemented for audits/inspections or any quality-related issues or concerns.
  • Ensure accurate finance reporting and trial delivery 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 Institutional Review Board (IRB)/Health Authority (HA) approvals, if applicable.
  • May contribute as a mentor, champion, or representative of functional areas in process initiatives, as required and if applicable.

Requirements

  • Bachelor's or higher-level degree preferable in life science.
  • Minimum of 5 years of clinical research experience in the pharmaceutical industry or Contract Research Organization (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).