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Clinical Research Associate / Senior Clinical Research Associate- (Germany, Home-based) - IQVIA MedTech

Location: Frankfurt am Main, Germany
R1264679

At IQVIA Biotech, we offer a unique approach to serving biotech customers. A flexible model, therapeutically-aligned teams and dedicated resources in a transparent partnership. As a Senior Clinical Research Associate, you’ll have the opportunity to work directly with customers in a collaborative environment where you'll be part of a team bringing important treatments to patients.

In this highly specialized and dynamic role, you’ll utilize your extensive therapeutic knowledge to oversee uniquely-focused clinical studies. Working at the core of clinical research, you’ll be exposed to cutting-edge protocols and experience a dedicated partnership with your team like never before.

Join us and help reimagine the future of biotech.

  • Full Time
  • Level: Senior
  • Travel: Yes

Success profile

What makes a Senior Clinical Research Associate at IQVIA Biotech successful? Check out the top traits we’re looking for and see if you have the right mix.

  • COLLABORATIVE
  • INDEPENDENT
  • DETAIL-ORIENTED
  • ORGANIZED
  • EFFICIENT
  • PROBLEM-SOLVER

Explore this
career path

As you grow your CRA career at IQVIA Biotech, you’ll play an important role in helping our customers drive healthcare forward and impact the lives of patients around the world.

  1. CRA 1
  2. CRA 2
  3. Senior
    CRA 1
  4. Senior
    CRA 2
  5. Senior
    CRA 3

Quote

Lauren Heffron

“IQVIA empowers you to drive your own path within the organization. As no person’s route is the same and the clinical research landscape is forever changing, you are encouraged to continually seek career growth opportunities and to align your interests with your career goals.”

Lauren, Senior Clinical Research Associate 2

What you
can expect

  • Professional Development

    Resources that promote your career growth

  • Work-Life Balance

    Leaders that support flexible work schedules

  • Highly Specialized

    Roles that require specialty knowledge and training

  • Therapeutically Aligned

    Protocols aligned to your specific expertise

  • Variety

    Dynamic work environments that expose you to new experiences

  • Best-in-class Training

    Programs to help you build your therapeutic-knowledge

Clinical Research Associate / Senior Clinical Research Associate- (Germany, Home-based) - IQVIA MedTech

Apply now
Location: Frankfurt/Main, Hesse, Germany R1264679

Job description

IQVIA MedTech Clinical Solutions, including genae which is a fully owned business unit of IQVIA,  specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products.

IQVIA MedTech’s focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and patients.

We have a vacancy within our Clinical Monitoring Team for an (experienced) permanent Clinical Research Associate to join our team!

Basic Functions:

Participates in the preparation and execution of medical Device clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, monitoring and  close out visits to sites.  Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA MedTech and sponsors. Works closely with the Clinical Project Manager (CPM) to ensure all monitoring activities are conducted according to study requirements.

Responsibilities

  • Participates in the investigator recruitment process, performing site evaluation visits of potential investigators to evaluate the capability of the site to successfully manage and conduct the clinical study.
  • Coordinate activities with the site and internal departments in preparation for the initiation of the study. Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF and EDC system; monitoring activities and study close-out activities.
  • Assists in resolving any issues to ensure compliance with site file audits
  • Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA MedTech SOPs.
  • Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor.  Performs investigational product inventory. 
  • Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification and works with sites to resolve data queries and produce robust data.
  • May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Project Manger
  • Serves as primary contact between IQVIA MedTech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
  • Assists with, and attends, Investigator Meetings for assigned studies.
  • Attends study-related, company, departmental, and external meetings, as required.
  • Ensures all study deliverables are completed per IQVIA MedTech and study timelines

KNOWLEDGE, SKILLS AND ABILITIES:

  • By preference, you have a (para-) medical or scientific degree and at least one (1) year of clinical research experience including monitoring, or a minimum of two years of experience in pharmaceutical data management or as a study coordinator
  • Fluent in English and German, by preference in more languages;
  • Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
  • Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
  • Able to handle several priorities within multiple, complex trials.
  • Able to reason independently and recommend specific solutions in clinical settings.
  • Able to work independently, prioritize, and work within a matrix team environment.
  • The working conditions will involve regular up to intensive national and international travelling

#CRAIBAJD

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 https://jobs.iqvia.com

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