Senior CRA & Country Head
- Sanaclis
- Nederland
- Onroerend goed & Facility management
- 3 maanden geleden
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:
- 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
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Research, Analyst, and Information TechnologyIndustries
Research Services
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