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Clinical Site Liaison (Neurology/ Rare Disease) - FSP

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Thermo Fisher Scientific

8d ago

  • Job
    Full-time
    Senior Level
  • Research & Development
    Healthcare
  • Milan

AI generated summary

  • You should have a relevant bachelor’s degree, 6+ years in Biotech/pharma, experience in site engagement or monitoring, a valid driver’s license, and a background in neurology or rare diseases.
  • You will engage sites, facilitate trials, support patient recruitment, monitor compliance, collaborate with teams, and optimize processes in neurology clinical research.

Requirements

  • 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
  • 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

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 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 Principal 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 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 the client, 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.

FAQs

What is the work schedule for the Clinical Site Liaison position?

The work schedule is standard, Monday to Friday.

What are the environmental conditions for this role?

The environmental conditions are office-based.

What type of clinical experience is required for this position?

A minimum of 6 years of experience in Biotech or pharma is preferred, specifically in roles including site engagement and/or clinical trial monitoring.

Is travel required for this job?

Yes, national travel is required, and occasional international travel may also be necessary.

What educational background is needed for this role?

A Bachelor’s degree in a scientific or health-related field is required, such as medical, para-medical, biology, biomedical sciences, or pharmacy.

Is experience in specific disease areas preferred for this position?

Yes, prior experience in Neurology, Auto-immune, and rare disease backgrounds is preferred.

What skills are important for success in this role?

Important skills include knowledge of ICH-GCP, excellent communication and relationship management, leadership abilities, organizational skills, and experience with tools and systems for managing clinical studies.

Will I be involved in patient engagement as part of this role?

Yes, the Clinical Site Liaison will work closely with patient advocacy groups and may attend events to engage with patient groups.

How does this position contribute to clinical trials?

This role supports the conduct and patient recruitment of global clinical trials at investigative sites, ensuring quality and efficiency throughout the trial process.

What is the FSP model mentioned in the job description?

The FSP (Functional Service Partnership) model is a partnership between Thermo Fisher Scientific and clients, where employees are sourced to work with a specific client for clinical trials.

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Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.