For our client, a Belgian, multinational pharma, we are looking for a Clinical Site Manager to reinforce our ICON team! Our sponsor is specialised in following disease area's: neurology, immunology and rare diseases. 

In this role you will have the opportunity to be focussed on maximizing site performance and site engagement for your clinical studies. You will be sharing your strong clinical operational and therapeutic expertise (scientific, clinical, disease states, and treatment alternatives knowledge within the therapeutic area(s)) to support the execution of the clinical studies.

We are eager to welcome enthusiastic candidates, that are driven by science and clinical trials to create a better future for the patient.

Scope of the role is to:

Maximize site performance and engagement in the clinical studies by leveraging deep clinical and therapeutic expertise. Oversee planning and management of monitoring activities and site operations to ensure compliance with the client's SOPs, GCP, and regulatory standards. Build strong site relationships to ensure high-quality execution of clinical trials. Collaborate with internal teams, external partners, and vendors, providing operational support to project managers to deliver studies on time and to required quality standards. Identify and develop high-performing investigative sites for the company's clinical programs.

Site Engagement Responsibilities:

• Develop and execute the Site Engagement Strategy in collaboration with the Clinical Team and internal stakeholders across all trial phases.

• Support site engagement activities by understanding the competitive landscape, identifying trial barriers, and using motivational strategies to drive study delivery.

• Build and maintain a global network of high-performing sites through consistent, multi-channel communication to increase site interest and partnership with the client

• Cultivate relationships with site engagement organizations and identify top-performing sites and KOLs for participation in forums and studies.

• Train and onboard new investigators for trials.

Monitoring Responsibilities:

• Conduct all types of site visits (Selection, Initiation, Monitoring, Close-out, Motivational, Support) and ensure site performance in setup, conduct, and data quality.

• Serve as primary site contact for study-related matters and maintain early and ongoing engagement with KOLs, sites, and patient organizations.

• Support CPMs in various aspects of study management including vendor oversight, training, logistics, site selection, study tracking, and eTMF management.

• Collaborate closely with Clinical Project Managers and Trial Teams to report on site status and progress.

• Ensure internal stakeholder alignment and communication on site activities.

• Contribute to development of key study documents (e.g., CRFs, protocols, ICFs, diaries) and participate in Investigator Meetings.

• Prepare and review monitoring tools (e.g., monitoring manuals) and contribute to CRO/vendor selection and contracting.

• Review and approve site regulatory packages; respond to regulatory/IRB queries as needed.

• Support development and updates of study-related materials (e.g., safety reports, Investigator’s Brochure).

• Train internal and CRO staff on study-specific monitoring requirements.

• Track monitoring performance, regulatory packages, visit reports, and query resolution.

• Conduct co-monitoring visits to ensure quality and implement corrective actions as needed.

• Utilize decentralized clinical trial (DCT) tools and methods.

• Share patient insights and innovation opportunities with innovation and TTI teams.

• Contribute to SOPs and ensure audit/inspection readiness in collaboration with the CPM/study team, addressing findings promptly.

• Minimum of Bachelor level in life sciences degree
• A minimum of 5 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator facing role
• You are strong in collaboration and facilitating work, processes,...
• You have excellent verbal, written and presentation skills with excellent command of English and local languages
• Able to work independently, within a great and colloborative team
• You are flexible, curious and driven!

ICON's Offer:

• Dedicated Line Manager as of the first day!
• Development opportunities and guided career path
• Competitive salary with extra-legal benefits, company car, home set-up allowance
• Homebased contract with the option to work from the client's office

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

#LI-Hybrid

#LI-VV1