Principal Clinical Scientist, Clinical Science Analytics & Insights

Tbwa Chiat / Day Inc; Santander; A distancia; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

A leading company in clinical research is seeking a Principal Clinical Scientist to work remotely in Spain. The role involves managing clinical science operations for trials, focusing on oncology, data visualization, and compliance with clinical standards. Candidates should possess a strong medical background and extensive experience in clinical research.

Formación

• 8 years of clinical research experience required.
• Minimum 1 year of leadership experience.
• Proficiency in medical terminology essential.

Responsabilidades

• Manage operational clinical science functions from study start-up to database lock.
• Lead CSAI services and support data cleaning processes.
• Conduct scientific data reviews and ensure compliance with study plans.

Conocimientos

Oncology experience

Clinical standards knowledge

Data visualization

Regulatory guidelines knowledge

Communication skills

Time management

Educación

Bachelor’s degree in science or health-related field

Medical degree (RN, OCN, RPH, PharmD)

Herramientas

EDC systems

Data visualization tools

Descripción del empleo

Principal Clinical Scientist, Clinical Science Analytics & Insights

Remote, Spain

Precision for Medicine is recruiting an experienced Principal Clinical Scientist to work remotely in Poland, Hungary, Serbia, Romania, Slovakia, Spain, or the UK.

Position Summary:

The Principal Clinical Scientist should have a strong knowledge of medical and oncology standards relevant to clinical trials, especially in solid and liquid tumors. The role involves managing the operational clinical science functions from study start-up to database lock, focusing on scientific insights and data visualization to support data cleaning within the cross-functional team. The candidate must be a subject matter expert in applying clinical knowledge, guidelines, and standards of care to clinical trial data review. A medical-related degree (RN, OCN, RPH, PharmD, etc.) is required.

Essential functions include but are not limited to:

1. Leading CSAI services per study scope of work on assigned projects.
2. Providing scientific expertise for data capture, review, and cleaning.
3. Supporting the development and implementation of process flows for cross-functional data cleaning.
4. Managing data cleaning processes to support study data deliverables.
5. Managing Medical Monitor review of subject data.
6. Reviewing protocols from a scientific operational perspective.
7. Providing scientific input to Data Management for study documentation.
8. Supporting UAT for CSAI programmed outputs.
9. Collaborating on departmental communication regarding data review and updates.
10. Supporting risk identification and management for studies.
11. Assisting in project and budget management.
12. Ensuring documentation compliance with study plans and SOPs.
13. Conducting scientific data reviews using programmed outputs and guidelines.
14. Overseeing queries in EDC systems and providing status updates.
15. Managing UAT and training for CSAI outputs.
16. Participating in study meetings and presentations.
17. Supporting study-specific committees and review processes.
18. Contributing to candidate interviews and business development activities.
19. Performing other duties as assigned.

Qualifications:

• Bachelor’s degree or equivalent in science or health-related field with proficiency in medical terminology.
• At least 8 years of clinical research experience or proven competencies.
• Minimum 1 year of leadership experience.

Other requirements:

• Oncology experience with knowledge of clinical standards and biomarkers.
• Experience across trial phases I-III.
• On-site monitoring or data review experience preferred.
• Experience with EDC systems and data visualization tools.
• Proficiency in computer skills and professional English language skills.
• Knowledge of FDA, ICH, GCP regulations.
• Ability to travel domestically and internationally.

Highly preferred:

• Medical degree (RN, OCN, RPH, PharmD, etc.)
• Database build experience.

Competencies and Skills:

• Advanced oncology and medical terminology knowledge.
• Continuous learner with self-research skills.
• Knowledge of regulatory guidelines and clinical trial processes.
• High ethical standards and integrity.
• Operational management in a global environment.
• Strong time management, negotiation, and decision-making skills.
• Self-motivated with remote working capability.
• Flexible and results-oriented mindset.
• Financial management skills.
• Excellent communication and presentation skills.