RWE Site Manager with Experience and German Language

IQVIA · Sofia, Bulgaria

Job Overview

With applicable guidance, responsible for remote site monitoring and study delivery activities to ensure sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. May monitor and/or co-monitor on-site when needed. GERMAN LANGUAGE IS MANDATORY.

Essential Functions

  • Completes appropriate therapeutic, protocol and clinical research training to perform job duties. Works collaboratively with other functional groups such as Clinical Operations Lead (COL), Project Management, Data Management, and Safety teams.

  • Supports site onboarding into study delivery phase, ensuring readiness for study execution including system access, training completion, and operational alignment with protocol requirements.

  • Perform, as needed, initiation, remote monitoring, and close-out activities in accordance with contracted scope of work, using Good Clinical Practices (GCP), applicable regulations, SOPs and work instructions. May monitor and/or co-monitor on-site when needed.

  • Serves as a primary contact between the business and the investigator site and ensures proper documentation of site management communications. Serves as back-up to other Site Managers (SMs).

  • In collaboration with assigned field Clinical Research Associates (CRAs), performs routine site management and delivery activities, including:

    • Site training and ongoing support
    • Addressing site questions and protocol clarifications
    • Patient recruitment and retention support
    • Study supplies and logistics coordination
    • Oversight of protocol compliance and study conduct

  • Collaborate with field CRAs to identify, resolve, and document site issues and action items, ensuring timely mitigation of risks impacting delivery.

  • Reviews the quality and integrity of patient data at assigned sites through the remote review of electronic Case Report Form (CRF) data. Ensures timely transmission of clinical data and works with sites to resolve data queries.

  • Drive data cleaning and readiness for database lock, including:

    • Query management and resolution
    • Patient profile and data listings review
    • Coordination of casebook finalization and investigator signatures

  • Ensures accurate completion and maintenance of internal systems, databases and tracking tools with site-specific information, including:

    • Visit reports and follow-up documentation
    • Essential document tracking
    • Study progress and performance updates

  • Provides input and updates to the assigned COL regarding site performance, enrollment, data quality, and delivery milestones. Escalates risks or delays as needed.

  • May assist with and attend Investigator Meetings and site engagement activities to support study delivery.

  • Authorized to request onsite visits and/or audits where necessary to validate performance and ensure compliance.

  • May support site payment activities, ensuring alignment with study progress, deliverables, and contractual timelines.

  • May provide guidance to less experienced clinical staff, including coaching on site management, monitoring practices, and delivery-focused activities.

Qualifications

  • Bachelor's Degree preferred (scientific discipline or health care preferred, or as required by local policies)

  • Minimum of 1 year of relevant clinical experience preferred

  • Equivalent combination of education, training and experience may be acceptable

  • Pre-intermediate knowledge of clinical research processes and medical terminology

  • Working knowledge of study execution and delivery lifecycle

  • Written and verbal communication skills including good command of English language

  • Good organizational and problem-solving skills

  • Ability to manage multiple priorities across different sites and studies

  • Ability to meet deadlines and adhere to project timelines

  • Ability to work independently on routine tasks and apply critical thinking with guidance as needed

  • Ability to build and maintain effective relationships with sites, colleagues, and stakeholders

  • Understanding of electronic data capture (EDC) systems and data review processes

  • Pre-intermediate knowledge of ICH-GCP guidelines and applicable regulations

  • Understanding of different study designs and their operational implications

  • Computer skills including Microsoft Word and Excel

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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