Senior Clinical Data Science Lead

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Lead the analysis, interpretation, and management of clinical data for clinical trials.

• Supervise clinical data science workstreams to ensure that deliverables adhere to quality and timeline expectations.

• Direct Clinical Data Management activities from the initiation of the study through to database closure and clean database declaration.

• Provide oversight, guidance, mentorship, and training to Data Management staff.

• Serve as an experienced Clinical Data Management resource and escalation point for global, cross-functional study teams.

• Develop and maintain study-specific data management components and specifications, which include eCRFs, study metadata, edit checks, Data Validation Documents, and protocol deviation documentation.

• Collaborate with EDC developers on eCRF and database structure specifications, contributing to EDC User Acceptance Testing.

• Manage data cleaning activities, including queries, query responses, query status, and consistency checks on external data.

• Coordinate SAS programming requirements for edit checks and derivations, contributing to data monitoring activities.

• Prepare data listings and extracts for medical reviews, study reporting, and cross-functional activities.

• Develop and coordinate plans for database closure.

• Identify and communicate issues that impact study timelines or data quality, working with study teams to address them.

• Ensure that Clinical Data Management activities are documented throughout the study lifecycle.

• Support training and educational initiatives for Data Management colleagues.

⛳️ Requirements

• Bachelor’s degree or equivalent in Natural Sciences, Informatics, Medical Documentation, or a related field.

• Over 5 years of experience as a Clinical Data Manager, with significant responsibilities in clinical projects and study teams.

• Strong understanding of the drug development process and extensive experience with clinical data management methodologies and technologies.

• Proven track record in managing clinical data from study initiation to clean database declaration.

• Experience working within global, cross-functional teams and collaborating with Study Management, Medical, EDC Development, Statistics, and Medical Writing.

• Ability to interpret Clinical Study Protocols, Statistical Analysis Plans, and Medical Review Plans, translating them into data management specifications.

• Experience in developing specifications, including CRFs, metadata, protocol deviation documents, and edit check specifications.

• Solid understanding of ICH and GCP regulations and guidelines.

• Experience in training and/or mentoring junior Data Management colleagues.

• Strong project management, organizational, and self-management abilities.

• Experience in leading and contributing to global, cross-functional teams towards key study milestones.

• Excellent written and verbal communication skills in English; fluency in spoken English is required, along with strong local-language communication skills.

• Good understanding of IT processes and databases utilized in Clinical Development.

• Legal right to work in the country where the role is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.