Senior Clinical Scientist

This is a fully remote position, open to applicants in Spain.

📋 Description

• Design and implement clinical studies aimed at assessing the safety and effectiveness of cutting-edge treatments.

• Assist in the formulation and drafting of clinical trial protocols that adhere to rigorous scientific and clinical standards along with relevant regulations.

• Aid in identifying, drafting, and executing amendments to the clinical protocol while closely collaborating with the clinical lead.

• Participate in the creation of study-specific documents, including the preparation of clinical sections for key regulatory submissions such as Investigator’s Brochures, briefing books, safety updates, and submission dossiers.

• Help review and author clinical trial documents for CTR activities and publications when applicable.

• Support pharmacovigilance efforts, such as contributing to the creation and assessment of aggregate reports, patient narratives, and attending pharmacovigilance monitoring meetings.

• Assist with regulatory tasks, including the preparation for meetings with regulatory agencies.

• Develop training materials, share best practices, and provide training to the wider clinical trial teams.

• Aid in the preparation for and, if necessary, participate in study-level meetings, including Investigator Meetings, Data Monitoring meetings, and others.

• Support and guide the establishment of data review strategies, ensuring consistent implementation of protocol-level deviations, eligibility criteria, study assessments, and other protocol aspects across diverse locations.

• Include assistance with Case Report Form (CRF) development and the implementation of data capture tools.

• Possess extensive expertise to conduct thorough and high-quality clinical data reviews, identifying clinical data insights through ongoing patient-level review and trend analysis to assist in Interim Analysis, Database, and Post Lock activities, as well as the resolution of scientific and medical issues during the study lifecycle.

• Strive to enhance the quality of reviews and insights with a focus on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and pinpointing cases for medical review.

• Provide insights and facilitate enhancements to the data review process by identifying redundant reports, implementing innovative data analysis methodologies and tools, and ensuring their continuous improvement.

⛳️ Requirements

• Advanced degree in life sciences, healthcare, or a clinically relevant field.

• A minimum of 5+ years of experience as a Clinical Scientist.

• Expertise in the HIV therapeutic area is required, preferably in a Phase 1 – 3 clinical research setting; ideally complemented by knowledge in Vaccine Development or Infectious Diseases.

• Preferred familiarity with the setup, organization, and execution of global clinical studies within a pharmaceutical company or contract research organization (CRO) environment.

• Solid understanding of clinical data collection and reporting principles, with a proven ability to utilize standard systems and tools (e.g., EDC systems, Excel, etc.) for data gathering, analysis, and reporting.

• Demonstrated capability to promote continuous improvement of processes, systems, and tools.

• Experience working in a matrix environment, with a strong ability to informally influence and collaborate without direct authority.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.