Clinical Scientist

PRA International; Brasil; Presencial; USD 50.000 - 85.000; Tempo integral

Resumo da oferta

A leading company in clinical development is seeking a Clinical Scientist to support early and late-stage clinical programs. The role involves overseeing clinical studies, analyzing data, and ensuring compliance with regulations. Ideal candidates will have strong analytical skills and the ability to work in a collaborative environment.

Serviços

Competitive salary

Work-life balance opportunities

Inclusive culture and environment

Qualificações

• In-depth knowledge in analysis and interpretation of clinical data (safety and efficacy).
• Strong oral and written communication skills.
• High level of organizational and project management skills.

Responsabilidades

• Conduct clinical studies and medical monitoring.
• Analyze clinical trial data including safety and efficacy.
• Develop clinical study reports and protocols.

Conhecimentos

Communication

Data Analysis

Project Management

Biostatistics

Descrição da oferta de emprego

Overview

As a Clinical Scientist, you will provide scientific, clinical, and operational input to early and late-stage clinical development programs with an emphasis on protocol-specific, in-life clinical data monitoring activities. This role will work on cross-functional study teams on design, execution, and monitoring of clinical trials, as well as data interpretation and communication. This role will also serve as a point of contact for investigators in day-to-day clinical study needs.

Responsibilities

What you will be doing:

• Works with cross-functional team with oversight by the Medical Lead to conduct clinical studies, including clinical and safety data review, site interface on clinical study content, preparation of meeting materials, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update reports, and study close-out activities.
• Conducts medical monitoring reports, safety reviews, site interactions, and reviewing TFLs.
• Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead.
• Analyzes and synthesizes information to assess issues relating to protocol conduct and/or individual subject safety.
• Develops protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents with minimal direction from the Medical Lead.
• Collaborates with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations.
• Represents the client to outside personnel in the development of clinical protocols and study conduct
• Contributes to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors.
• Leads literature reviews as needed.
• Prepares scientific material for conference presentations or publications.

Qualifications

You are:

• In-depth knowledge in analysis and interpretation of clinical data (safety and efficacy); proficient knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
• Ability to make independent, timely and appropriate decisions.
• Strong oral and written communication skills to explain difficult information and solid computer/analytical skills.
• Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
• High level of organizational and project management skills.
• Flexibility to accommodate changes in team and project needs.
• Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.https://careers.iconplc.com/reasonable-accommodationsInterested 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.