Principal Clinical Scientist, Clinical Science Analytics & Insights

Tbwa Chiat / Day Inc; Granada; A distancia; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

An innovative firm is seeking a Principal Clinical Scientist to lead clinical science analytics for oncology trials. This role involves managing data processes, ensuring compliance with medical standards, and providing expertise in clinical trial data review. The ideal candidate will possess extensive experience in clinical research, particularly in oncology, and demonstrate strong leadership skills. Join a dynamic team where your contributions will directly impact patient outcomes and drive scientific advancements. If you are passionate about clinical science and thrive in a remote work environment, this opportunity is perfect for you.

Formación

• 8+ years of clinical research experience with a focus on oncology.
• Strong leadership skills with experience in managing clinical trials.
• Proficiency in medical terminology and FDA regulations.

Responsabilidades

• Lead clinical science analytics for clinical trials from start to finish.
• Manage data cleaning processes and oversee medical monitor reviews.
• Facilitate cross-departmental communication and manage study risks.

Conocimientos

Oncology knowledge

Clinical research experience

Leadership experience

Data review

Medical terminology proficiency

Time management

Communication skills

Educación

Bachelor's degree in science or health-related discipline

Medical degree (highly preferred)

Herramientas

EDC systems

Data visualization tools (e.g., JReview)

Descripción del empleo

Principal Clinical Scientist, Clinical Science Analytics & Insights

Location: 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 working knowledge of medical and oncology standards applicable to clinical trials, preferably in solid and liquid tumors. This role manages the operational clinical science function from study start-up through database lock for projects focused on scientific and indication-specific data insights, supporting scientific and clinical data review. The role requires serving as a subject matter expert in clinical knowledge, guidelines, and standards of care for clinical trial data review. A medical-related degree (RN, OCN, RPH, PharmD, etc.) is required.

Essential functions include but are not limited to:

1. Lead CSAI services per study scope of work on assigned projects.
2. Provide expertise on scientific data capture, review, and cleaning.
3. Support the development and implementation of processes for integrated data cleaning across departments.
4. Manage data cleaning processes to support data deliverables.
5. Oversee Medical Monitor review of subject data.
6. Review protocols from a scientific operational perspective.
7. Contribute to the development of study documentation like eCRF specifications and edit checks.
8. Support EDC UAT and other data management activities.
9. Facilitate cross-departmental communication regarding data review and system updates.
10. Identify and manage study risks related to CSAI.
11. Assist in project and budget management for CSAI activities.
12. Ensure proper documentation in eTMF as per study plans and SOPs.
13. Conduct or support scientific data reviews using programmed outputs and guidelines.
14. Manage queries and review study data review findings.
15. Develop and test CSAI programmed outputs.
16. Provide training for CSAI team members and study sites.
17. Participate in study team meetings and presentations.
18. Support study-specific committees and review reports.
19. Participate in candidate interviews and business development activities.
20. Perform other duties as assigned.

Qualifications:

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

Other Requirements:

• Oncology therapeutic experience, understanding of standards of care and biomarkers.
• Experience in phases I-III trials.
• On-site monitoring or data review experience preferred.
• Experience with EDC systems and data visualization tools (e.g., JReview).
• Proficiency in computer skills and professional English language skills.
• Knowledge of FDA and 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 knowledge in oncology and medical terminology.
• Desire for continuous learning about medical standards of care.
• Knowledge of FDA and ICH-GCP guidelines and SOPs.
• High integrity and ethical standards.
• Ability to independently manage operational functions in a global environment.
• Excellent time management, negotiation, and decision-making skills.
• Self-motivated with remote work capability.
• Ability to handle multiple demands and shifting priorities.
• Results-oriented, accountable, flexible, and collaborative.
• Financial management skills at the project level.
• Excellent communication and presentation skills.