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

IQVIA LLC; Amsterdam; Hybrid; EUR 52,000 - 72,000; Full time

Benefits offered by this job

Company car or mobility allowance

Technology bundle: laptop and iPhone

Career advancement programs

Home office setup support

Time-off policy and vacation days

Pension plan and insurance

Supplementary health insurance options

Job summary

IQVIA Netherlands is seeking a motivated Clinical Research Associate II to join our sponsor dedicated model. Based in the Netherlands, you will perform site monitoring visits and support trial execution in line with GCP/ICH.

You will work with site staff to manage recruitment, data queries, and ensure TMF/ISF accuracy. A Bachelor’s degree and 18 months on-site CRA experience are preferred, with fluent Dutch (C1) and English.

Qualifications

• Bachelor's Degree in scientific discipline or health care.
• Minimum of 18 months on-site CRA monitoring experience in CRO/pharma environment.
• Full professional fluency in Dutch (C1) and English; strong medical writing skills.
• Good knowledge of GCP/ICH regulatory requirements.
• Organizational and problem-solving skills.
• Exceptional interpersonal and cross-cultural communication skills to build strong partnerships.
• Collaborative mindset to work effectively with cross-functional global teams.

Responsibilities

• Perform site monitoring visits in line with contracted scope and GCP/ICH requirements.
• Drive site recruitment planning and track progress to support predictability.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol compliance and quality.
• Escalate quality issues as appropriate.
• Manage progress of studies by tracking regulatory submissions, recruitment, CRF completion, data queries.
• May support start-up phase.
• Ensure site documents are filed in the TMF and ISF is maintained.
• Create and maintain documentation of site management and visit findings.
• Collaborate with study team members for project execution support.
• May support development of site-specific recruitment plans.

Skills

Dutch language

English language

Organizational skills

Problem-solving

Interpersonal skills

Cross-cultural communication

Collaborative mindset

Team collaboration

Education

Bachelor's Degree

Degree in scientific discipline/health care

Job description

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 18 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments.

Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.

No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.