Location: New York, NY
Company: Argenx
Proven expertise in engaging, building and maintaining excellent working relationships with country / region specific investigative sites, KOLs, site networks and Patient Advocacy groups (PAG). From within the Trial Operations (Trial Ops) team, closely work together with the clinical trial/ indication teams and with CROs and other vendors.
Collaborate with the argenx Global Patient Advocacy (GPA) group as well as with the Medical Affairs group (MSLs). Roles and Responsibilities: Participate in neurology franchise 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 Trial Ops 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 Glo Sa M 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 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 neurological 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, shop, 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 Valid driver's license Ability for travel nationally and occasional international travel Experience in global clinical trials is a plus Prior experience in Neurology, Auto-immune and rare disease background #LI-Remote At argenx we strive to create a welcoming and inclusive environment.
Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, interaction, interactionual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at xyz X@. Only inquiries related to an accommodation request will receive a response. PDN-9acb1f0c-bb12-4f61-a531-23c671014bd6
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