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Solliciteren



Senior Clinical Research Associate


We are looking for an experienced Senior CRA & Country Head to strengthen our clinical operations in Belgium! Job Requirements: Higher education – preferred qualification in nursing, life sciences or medical sciences Minimum 5 years experience working at a CRO Must have experience with regulatory submissions. Profound knowledge of clinical research processes and medical terminology Expert knowledge of ICH GCP, and international and local regulatory requirements English language proficiency of minimum level C1 (ref. CEFR) – fluent in written and spoken English Driving license B Job Responsibilities: Ensure that Clinical Trial is conducted, recorded, and reported in accordance with all applicable international and local regulations and guidelines, good practices, SOPs and Clinical Trial Protocol. Ensuring data quality and integrity meet acceptable clinical standards and the rights and safety of patients involved in a study are protected. Perform and coordinate all aspects of the clinical monitoring and site management process. Conduct remote and on-site visits to assess protocol and regulatory compliance and manage required documentation. Develop collaborative relationships with investigational sites, act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects rights, well-being, and data reliability; and you would ensure audit readiness. Serve as a facilitator of Clinical Trial conduct in the respective area in terms of identifying qualified sites and investigators, facilitating communication between Sponsor and regulatory authorities and trial sites. Apart from general CRA responsibilities, you would mentor and supervise less experienced colleagues and ensure their professional development and quality of their performance. As country head you will also be responsible for the overall functioning of the local office , including its set-up, compliance with legal requirements, facility, technical and human resources, cooperation with headquarters and and everyday local operations. What We Offer: Competitive salary Flexible working hours and home-based working option Great work-life balance (You will not be overwhelmed with projects as we believe in quality over quantity) Career growth and development opportunities in a continuous learning culture Friendly environment in a privately owned international company Additional paid day off on your birthday Other company benefits based on mutual agreement You can apply via the link or send a CV directly to:careers@sanaclis.com *SanaClis is an equal opportunity and inclusive employer

Solliciteren