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