[Remote] CTM FSP Brazil (Neuroscience) at Thermo Fisher Scientific

Brazil

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, Clinical ResearchIndustries

Requirements

Clinical trial operational experience and deep understanding of patient pathways and trial recruitment
Proven expertise in engaging, building and maintaining excellent working relationships with country/region specific investigative sites, KOLs, site networks and Patient Advocacy groups (PAG)
Knowledge of ICH-GCP and other applicable legislation
Ability to quickly understand complex neurological diseases

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 client 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 (e.g., 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 client 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 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 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 (e.g., 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

Clinical Trials

Patient Recruitment

Site Engagement

KOL Management

Feasibility Studies

Site Selection

Contract Negotiation

Patient Pathways

Neurology

Trial Operations

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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