Clinical Site Liaison

The Clinical Site Liaison (CSL) is a field based expert who supports the conduct and the patient recruitment of argenx global clinical trials at investigative sites, through local and relational support.

ROLES AND RESPONSIBILITIES:
The CSL responsibilities include:

- Ensure Canada is well represented in argenx clinical trials by bringing studies to Canadian investigators and ensure their success.
- Build long-term, peer-to-peer medical/scientific relationships with Canadian investigators and study coordinators.
- Work with local Canadian Patient Advocacy Groups to raise clinical trial awareness.
- Participate in franchise, indication and study-level feasibility activities through providing key country/ regional and site specific knowledge including patient pathways and operational execution.
- Interface and act as a local argenx TrialOps representative, an expert on the clinical trial protocol(s) and SME providing the sites with knowledge and awareness about the current and upcoming clinical trials.
- Lead and engage in local site, KOL and network engagement initiatives in view of the clinical trials.
- Contribute to the trial specific site feasibility / selection strategy and collaborate with the Clinical Trial Team (CTT) and CRO to support the site start-up process as needed.
- Facilitate with the site contract negotiation/signature as needed, collaborate with the GloSaM group.
- Proactively work to fully understand all matters that impact the successful patient recruitment and high quality conduct of the clinical trial at each site, eg the Principle Investigator (PI) and site preferences and best practices on clinical trials, standard of care treatments, competing studies etc. Ensure a supportive relationship with clinical sites and trial personnel.
- Proactively work to fully understand the patient voice, preferences and pathway(s). Closely work with the argenx GPA team. Speak to patient groups and support groups, live events and conferences as allowed by local / regional guidance. May also attend live and virtual patient events to assist in responding to questions about argenx, the trial(s) and other information on Mode of Action (MOA).
- May participate in monitoring oversight activities such as accompanying the CRO CRA during site visits. This to ensure high quality conduct and execution of the clinical trials according to the protocol and ICH GCP and local regulatory requirements.
- Closely work together with the Medical Affairs colleagues, eg the MSLs to ensure optimal synergies in the respective site contacts and support.
- Optimize site engagement for a specific trial and across the neurology franchise to ensure site engagement and quality for the site-level enrollment and execution of every trial.
- Oversee and track patient recruitment for the regional sites and pro-actively identify ways to prevent recruitment delays.
- Pro-actively identify issues and look for solutions in the assigned clinical trial and timely escalate them to the respective study CTM, CODL, Global Head of Clinical Site Communication, Recruitment and Liaisons, Head of Trial Operations and/or Senior Management, as needed.
- Identify efficiencies, best practices and lessons learnt and ensure they are shared across trials/indications/compounds.
- Search for and embrace innovation.
- May be asked to provide input to the clinical development strategy/plan.
- Participate in workstreams and provide input to procedures/SOPs/WIs and related documents.

SKILLS AND COMPETENCIES:

- Knowledge of ICH-GCP and other applicable legislation.
- Ability to quickly understand complex disease areas, treatments and clinical development plans.
- Understand the healthcare therapeutic landscape, patient pathways and investigative sites.
- Excellent communication and presentation skills and relationship management of multiple stakeholders, internally and externally, including sites, KOLs, networks, PAGs, CROs and others.
- Leadership with the ability to overcome challenges, seek opportunities to remove barriers, influence without authority.
- Highly developed organizational skills, problem solving, analytic and able to prioritize.
- Experience with tools and systems for managing clinical studies.

EDUCATION, EXPERIENCE AND QUALIFICATIONS:

- Bachelor’s degree, Scientific or health related field University degree - medical or para-medical (MD, Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience.
- Minimum of 6 years of experience in Biotech / pharma preferably in roles including site engagement and / or clinical trial monitoring experience.
- Experience in global clinical trials is a plus.
- A strong understanding of the drug development process.
- Robust knowledge of local regulations and practices related to industry interactions with Canadian healthcare professionals.
- Valid driver’s license.
- Ability for 40-50% travel nationally and occasional international travel.
- Fluency in French language is preferred.