IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Within our Sponsor dedicated model, our team contributes to the pipelines of the specific sponsor and therefore our CRAs are ‘indication and molecule experts’. We set ourselves apart with collaboration and face to face contact both at start up and during the clinical study.
Leadership recognises the skills, talent and experience of our clinical teams and strives to build upon this as the function evolves and grows. Our managers understand the sponsors priorities and the individual aspects of each model. Focus is given to career development from day one, including new hire orientation and onboarding, day to day problem solving and training and development.
Additionally, IQVIA’s sponsor dedicated business works with the Sponsors SOP’s, creating more continuity for both parties.
Our models offer excellent opportunities for experienced CRA’s to expand their knowledge and skills.
IQVIA Netherlands are currently seeking motivated Clinical Research Associate II practitioner to join our unique and dynamic Sponsor dedicated model.
This is a role based in the Netherlands
Your Role:
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
Your Profile:
- Bachelor's Degree Degree in scientific discipline or health care
- Minimum of 12 months of independent, on-site monitoring experience as a CRA within a CRO or pharmaceutical environment.
- Full professional fluency in both Dutch (minimum C1 level) and English, including strong medical writing skills for reports.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Organizational and problem-solving skills.
- Exceptional interpersonal and cross-cultural communication skills to build strong, trusted partnerships with Dutch site investigators and medical staff.
- A collaborative mindset to work effectively with cross-functional global teams, project managers, and local study coordinators.
What we offer:
- Choice of a company car (eligible for private use) or a flexible mobility allowance, fully covering fuel, insurance, and maintenance.
- Premium technology bundle to support your daily operations, including a laptop and an iPhone.
- Strong focus on career advancement, featuring dedicated training programs, learning resources, and pathways to build clinical or leadership expertise.
- Home office setup support, alongside an annual wellness reimbursement to fund your sports and wellbeing activities.
- Comprehensive time-off policy, including competitive annual vacation days and flexible year-end leave options.
- Premium benefits package featuring a robust pension plan, multiple corporate insurance coverages, and social activities.
- Optional partial reimbursement for supplementary health insurance policies to support your healthcare needs.
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.