Senior Clinical Research Associate - Sponsor dedicated - Netherlands - Home based (m/w/d)

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 Senior Clinical Research Associate 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 3 years 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.