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Job type: Permanent

Discipline: VP/Head of Clinical Operations

Location: Belgium

Job title: Senior Site Director, Clinical Operations
Location: Belgium

Are you ready to lead a cutting-edge Clinical Operations Site and assist in the acceleration of clinical breakthroughs in biotech?

��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is seeking a Site Director, Clinical Operations to be responsible for overall clinical site management. This includes site identification, feasibility, pre-study site evaluation, study start-up, site initiation, patient recruitment, monitoring, site close-out activities, inspection readiness and local regulatory and IRB/EC submissions clinical studies at designated sites in accordance with study protocol(s), Standard Operating Procedures, ICH-GCP guidelines and all applicable regulatory requirements. Using available systems and tools, you will monitor and oversee site activities both onsite and remotely to ensure that patients' rights, safety and well-being are protected and that the data generated at sites are complete and accurate. You will be accountable for patient enrolment and overall delivery of high-quality patient data in established timelines for all designated sites in Belgium and/or assigned region.

Responsibilities:

Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites
Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines
Develop and cultivate strong site relationships and ensure continuity of site relationships
Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
Identify, assess, escalate and resolve site performance or quality issues in a timely manner
Complete feasibility and site identification activities for new clinical studies
Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions
Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance
Responsible for the development of site-specific recruitment, retention and follow-up plans
Facilitate and support investigator site audits and/or inspection activities as needed
Perform remote data review and query resolution for designated sites
Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives
Contribute to the review of company's systems and procedures as needed

Key Skills and Requirements:

Bachelor's Degree in a Life Science discipline required
Bachelor's Degree in Nursing or RN a plus
Proven working years of direct site monitoring experience required
Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall drug development required
Thorough understanding of EMA, ICH and GCP guidelines and applicable local regulations
Excellent critical thinking skills and ability to understand complex patient histories, medical terminology and treatment landscapes
Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle
Detail-oriented, organized and committed to quality and consistency
Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs
Experience and proven proficiency in CTMS and eTMF systems preferred
Must be willing and able to travel within EU area, as required

If you are having difficulty in applying or if you have any questions, please contact Camille Sandres at c.sandres@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is acting as an Employment Agency in relation to this vacancy.

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