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

pIQVIA Netherlands are currently seeking a motivated Senior Clinical Research Associate practitioner to join our unique and dynamic sponsor dedicated model. /pbrLees de informatie in deze vacature zorgvuldig door om precies te begrijpen wat er van potentiële kandidaten wordt verwacht.brpThis role is based in the Netherlands. /pbrYour Rolebrullibr/liliPerform 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) guidelinesbr/liliWork with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.br/liliAdminister protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.br/liliEvaluate 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.br/liliManage 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.br/liliEnsure 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.br/liliCreate 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.br/liliCollaborate and liaise with study team members for project execution support as appropriate.br/liliIf applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.br/li /ulbrYour Profilebrullibr/liliBachelor's Degree Degree in scientific discipline or health carebr/liliMinimum of 3 years of independent, on-site monitoring experience as a CRA within a CRO or pharmaceutical environment.br/liliFull professional fluency in both Dutch (minimum C1 level) and English, including strong medical writing skills for reports.br/liliGood knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).br/liliOrganizational and problem‑solving skills.br/liliExceptional interpersonal and cross-cultural communication skills to build strong, trusted partnerships with Dutch site investigators and medical staff.br/liliA collaborative mindset to work effectively with cross-functional global teams, project managers, and local study coordinators.br/li /ulbrWhat We Offerbrullibr/liliChoice of a company car (eligible for private use) or a flexible mobility allowance, fully covering fuel, insurance, and maintenance.br/liliPremium technology bundle to support your daily operations, including a laptop and an iPhone.br/liliStrong focus on career advancement, featuring dedicated training programs, learning resources, and pathways to build clinical or leadership expertise.br/liliHome office setup support, alongside an annual wellness reimbursement to fund your sports and wellbeing activities.br/liliComprehensive time‑off policy, including competitive annual vacation days and flexible year‑end leave options.br/liliPremium benefits package featuring a robust pension plan, multiple corporate insurance coverages, and social activities.br/liliOptional partial reimbursement for supplementary health insurance policies to support your healthcare needs. xgiwjmb br/li /ulbrThuiswerkmogelijkheden zijn beschikbaar voor deze functie.