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Responsibilities
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.With team contributes to the pipelines of the specific sponsor and therefore our CRAs are ‘indication and molecule experts’.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.Additionally, IQVIA’s sponsor dedicated business works with the Sponsors SOP’s, creating more continuity for both parties.IQVIA Belgium are currently seeking motivated Senior Clinical Research Associate practitioner to join our unique and dynamic Sponsor dedicated model.Your RolePerform 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) guidelinesWork 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 maintaitoring 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 ProfileUniversity degree in scientific discipline or health careMinimum of 3 years of independent, on-site monitoring experience as a CRA within a CRO or pharmaceutical environment.Excellent communication skills nch, and English, both written and spoken.Good knowledge of, and skill licable 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 Belgium site investigators and medical staff.A collaborative mindset to work effectively with cross-functional global teams, project managers, and local study coordinators.Why join us?Grow your career with access to development resources, training, and advancement opportunitiesEnjoy the flexibility and trust to balance your professional and personal commitmentsExpand your therapeutic knowledge through dedicated learning and development programsBe part of a successful global organization with an excellent reputation and supportive cultureBenefit from a company car, mobile phone, and an attractive rewards and benefits packageIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
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