Principal Clinical Scientist, Clinical Science Analytics & Insights
Location: Remote, Spain
Precision for Medicine is seeking an experienced Principal Clinical Scientist to work remotely across Poland, Hungary, Serbia, Romania, Slovakia, Spain, or the UK.
Position Summary:
The Principal Clinical Scientist should possess 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 for projects focused on scientific and indication-specific data insights, visualization, and review. The candidate will serve as 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.
Key Responsibilities:
- Lead CSAI services per study scope on assigned projects.
- Support project teams in scientific data capture, review, and cleaning.
- Develop and implement processes for cross-functional data cleaning and ensure data quality.
- Manage data cleaning processes and timelines.
- Oversee Medical Monitor review of patient data.
- Review protocols from a scientific and operational perspective.
- Contribute to the development of study documentation such as eCRF specifications and edit checks.
- Support EDC UAT and other data review activities.
- Facilitate communication across departments regarding data capture and review trends.
- Identify and manage study risks related to CSAI processes.
- Assist with project and budget management.
- Ensure proper documentation in eTMF.
- Conduct scientific data reviews using programmed outputs and guidelines.
- Oversee query resolution in EDC systems.
- Provide status updates and escalate issues as needed.
- Develop and conduct UAT for CSAI outputs.
- Train CSAI staff and project teams.
- Participate in study meetings and presentations.
- Support study-specific committees and review reports as needed.
- Assist in candidate interviews and business development activities.
- Perform 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 equivalent competencies.
- Minimum 1 year of leadership experience.
Additional Requirements:
- Experience in oncology, with knowledge of clinical standards, biomarkers, and side effects.
- Experience in phase I-III trials.
- On-site monitoring and data review experience preferred.
- Experience with EDC systems and data visualization tools.
- Proficiency in computer skills and professional English communication.
- Knowledge of FDA and ICH/GCP regulations.
- Ability to travel domestically and internationally.
Preferred Qualifications:
- Medical degree (RN, OCN, RPH, PharmD, etc.).
- Experience with database build.
Skills and Competencies:
- Advanced oncology and medical terminology knowledge.
- Continuous learner with self-research capabilities.
- Strong understanding of clinical trial processes and regulations.
- High integrity and professionalism.
- Ability to independently manage operational functions globally.
- Excellent communication, negotiation, and critical thinking skills.
- Self-motivated, flexible, and results-oriented.
- Financial management skills at project level.
- Excellent presentation and written skills.
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