Principal Clinical Data Scientist

This is a fully remote position, open to applicants in United Kingdom, +6 more countries.

📋 Description

• Act as the CSAI functional leader for designated project teams.

• Oversee the operational clinical science function from study initiation to database lock.

• Offer scientific and clinical insights for data collection, review, cleansing, eCRF specifications, edit checks, completion guidelines, and EDC UAT.

• Facilitate and manage integrated cross-functional data-cleaning procedures for interim and final study outcomes.

• Supervise Medical Monitor assessments of subject data.

• Conduct protocol evaluations from a scientific operational viewpoint.

• Recognize study risks and address CSAI study-specific issues.

• Assist with monthly invoicing and variance management for the CSAI budget.

• Manage CSAI resource requirements and uphold project plans, guidelines, trackers, and eTMF documentation.

• Execute comprehensive and aggregate clinical data reviews using programmed outputs, listings, metrics, and graphs.

• Monitor and resolve queries in EDC systems, reporting or escalating findings from data reviews.

• Oversee the development and UAT of CSAI programmed outputs.

• Provide study-specific training and engage in internal and external meetings and presentations.

• Support data-related committees, TLF/CSR reviews, interviewing, business development, SOPs, training, and process enhancement initiatives.

• Uphold Precision’s commitment to quality and ethics while performing additional tasks as assigned by management.

⛳️ Requirements

• A Bachelor’s degree or an equivalent combination of education and experience in a science or health-related field, with a strong grasp of medical terminology.

• At least 8 years of clinical research experience or demonstrated competencies for this role.

• A minimum of 1 year of leadership experience.

• Familiarity with electronic data capture systems.

• Competence in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

• Professional proficiency in the English language, both written and spoken.

• Willingness to travel domestically and internationally on occasion, including overnight stays.

• Advanced knowledge in oncology and medical terminology, including disease assessment criteria, standards of care, and grading criteria.

• Understanding of FDA and ICH-GCP guidelines, relevant SOPs, regulatory standards, clinical trial processes, and clinical research functional areas.

• Capability to independently manage the CSAI operational function within a global, cross-functional context.

• Proficiency in applying financial management skills at the project level within the functional area.

🏝️ Benefits

• Flexibility to work remotely.

• Chance to operate in a global, cross-functional environment.

• Commitment to equal opportunity employment.

• Reasonable accommodations available for applicants with disabilities.