Clinical Scientist - Level Dependent Upon Experience

CTI Clinical Trial and Consulting Services; Lisboa; Presencial; EUR 65 000 - 90 000; Tempo integral

Resumo da oferta

CTI Clinical Trial and Consulting Services is seeking a seasoned Medical Monitor to oversee clinical trial safety and data review under the direction of a medical director. You will guide clinical teams on medical and scientific aspects and participate in data interpretation and decision-making.

The role emphasizes patient safety, trial integrity, and cross-team collaboration to optimize medical services in Medical Affairs.

Qualificações

• Make clinical decisions under MD oversight while collaborating with medical professionals.
• Apply clinical/patient care experience to research within clinical trials.
• Integrate scientific data with strong written and oral communication.
• Communicate effectively; analyze and interpret scientific data.
• Know GCP, regulations and data analysis techniques.
• Work independently or in a team to develop rigorous materials and presentations.
• Familiar with EDC systems and data visualization tools.

Responsabilidades

• Perform medical monitoring activities and oversee protocol review and safety data.
• Provide medical guidance to clinical teams on project aspects.
• Analyze clinical information and participate in problem-solving for trials.
• Lead medical data and safety reviews and identify safety trends.
• Ensure patient safety and trial integrity.
• Lead organizational activities to improve efficiency in Medical Affairs.

Conhecimentos

Clinical decision making

Clinical research experience

Medical writing

Verbal & written communication

Data interpretation

Data analysis

EDC systems

Data visualization

GCP/regulatory knowledge

MS Office

Team collaboration

Business concepts

Time management

Clinical care experience

Formação académica

PharmD / APRN / PA

PhD / MPH / advanced public health

Ferramentas

EDC systems

Data visualization tools

SharePoint

Adobe

MS Access

Descrição da oferta de emprego

• Perform medical monitoring activities under the oversight of a medical director. Medical monitoring activities include but not limited to review of the protocol and investigator’s brochure, review of medical budgets, preparing the medical monitoring plan, training project teams on the protocol, informing site identification and feasibility activities, supporting sites with clinical questions, participating in medical meetings, participating in medical and safety data review and analysis, and preparing and presenting data to internal and external stakeholders.
• Provide guidance to clinical teams on the medical and scientific aspects of assigned projects.
• Analyze and synthesize clinical information, participate in clinical problem-solving and clinical decision-making in the setting of clinical trials and studies.
• Lead and participate in medical data and safety reviews, including identifying critical safety trends and following up with sites/investigators to obtain additional information and to assess clinical events.
• Ensure patient safety and clinical trial integrity.
• Lead project-specific and department-wide organizational activities to optimize the efficiency and quality of medical services in Medical Affairs

What You'll Do:

• Perform medical monitoring activities under the oversight of a medical director. Medical monitoring activities include but not limited to review of the protocol and investigator’s brochure, review of medical budgets, preparing the medical monitoring plan, training project teams on the protocol, informing site identification and feasibility activities, supporting sites with clinical questions, participating in medical meetings, participating in medical and safety data review and analysis, and preparing and presenting data to internal and external stakeholders.
• Provide guidance to clinical teams on the medical and scientific aspects of assigned projects.
• Analyze and synthesize clinical information, participate in clinical problem-solving and clinical decision-making in the setting of clinical trials and studies.
• Lead and participate in medical data and safety reviews, including identifying critical safety trends and following up with sites/investigators to obtain additional information and to assess clinical events.
• Ensure patient safety and clinical trial integrity.
• Lead project-specific and department-wide organizational activities to optimize the efficiency and quality of medical services in Medical Affairs

What You'll Bring:

• Ability to make clinical decisions under the oversight of an MD, ability to work in collaboration with medical professionals.
• Ability to apply clinical/patient care experience to the research setting in the context of clinical trials.
• Ability to integrate scientific medical data with superior written and oral communication skills.
• Ability to communicate effectively (both verbally and in writing); ability to assimilate complex medical and/or research information; ability to analyze and interpret scientific data.
• Working knowledge of scientific and research principles and techniques of data analysis, interpretation, and clinical relevance
• Working knowledge electronic data capture systems and data visualization tools
• Working knowledge of Code of Federal regulations, ICH Guidelines, Good Clinical Practice, and applicable US regulatory guidance
• Ability to work effectively both independently and in a team setting to develop high quality, scientifically rigorous materials, and presentations.
• Working knowledge of Microsoft Office Suite including Word, PowerPoint, Excel, OneNote, as well as Access, Adobe, SharePoint, and others. Ability to become proficient in new software applications.
• Working knowledge of basic business-related financial and business development concepts
• Strong organizational, problem-solving, and time management skills; flexible and able to pivot to work toward changing priorities and goals; able to multi-task; self-driven and able to work in a fast-paced environment with competing priorities; able to receive constructive criticism and be open to learning new approaches for continued growth
• Advanced clinical degrees (e.g., PharmD, APRN, PA). Candidates with PhD and advanced public health degrees are also eligible.
• Direct experience in clinical research and clinical development, with experience reviewing and interpreting data especially in rare disease, solid organ transplant, hematology/oncology, cell and gene therapy, central nervous system disorders, and other complex indications
• Experience in direct patient care, clinical decision making, and working in collaboration with medical professionals preferred