Principal Clinical Data Scientist
P
Precision for MedicineClinical research
Remote, Hungary; Remote, Poland; Remote, Romania; Remote, Serbia; Remote, Slovakia; Remote, Spain; Remote, United KingdomFull-TimePrincipal
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Languages
- Professional use of the English language; both written & oral
- Experience
- Minimum of 8 years of clinical research experience or proven competencies for this position; Minimum of 1 year of leadership experience
- Required Skills
- Microsoft Office
Requirements
- Bachelor’s degree or equivalent combination of education and experience in a science or health-related discipline.
- Proficiency in medical terminology.
- At least 8 years of clinical research experience or proven competencies for the position.
- At least 1 year of leadership experience.
- Experience with electronic data capture systems.
- Experience with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
- Professional written and spoken English.
- Ability to travel occasionally, domestically and internationally, including overnight stays.
- Working knowledge of FDA and ICH-GCP, relevant SOPs, regulatory guidance, and the clinical trial process.
- Advanced knowledge of oncology and ability to apply disease assessment criteria, standards of care, and grading criteria to clinical trial data.
- Preferred: medical-related degree or qualification such as RN, OCN, RPH, or PharmD; database build, on-site monitoring, or data review experience.
- Preferred: experience with data visualization software such as JReview, solid and liquid tumors, phase I, II, and III studies, or global trials.
Responsibilities
- Lead implementation of Clinical Science Analytics & Insights services on assigned project teams.
- Advise project teams on scientific data capture, review, and cleaning.
- Support cross-functional processes for interim and final study data cleaning and deliverables.
- Manage Medical Monitor review of subject data and review protocols from a scientific operational perspective.
- Provide clinical and scientific input to eCRF specifications, edit checks, completion guidelines, and EDC user acceptance testing.
- Coordinate communication on data trends, EDC updates, and programming needs.
- Identify study risks and address CSAI study-specific deficiencies.
- Maintain project plans, guidelines, trackers, and applicable eTMF documentation.
- Conduct clinical data reviews using programmed outputs, issue or resolve EDC queries, and report findings.
- Develop and test CSAI programmed outputs, and provide study-specific training to scientists, project teams, or study sites.
View Full Description & ApplyYou'll be redirected to the employer's site
