Principal Clinical Data Science Lead

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

📋 Description

• Oversee Clinical Data Management processes throughout assigned studies, from the initiation phase to database closure and the declaration of a clean database.

• Provide guidance and oversight to Data Management personnel, including mentoring and training for less experienced team members.

• Serve as an expert resource in Clinical Data Management for global, cross-functional study teams and act as an escalation point for data management issues related to studies.

• Create and maintain data management components and specifications specific to each study, including eCRFs, study metadata, edit checks, Data Validation Documents, and documentation of protocol deviations.

• Collaborate with EDC developers to define eCRF and database structure specifications and participate in EDC User Acceptance Testing.

• Oversee data cleaning processes, including managing queries, responses, query status, and consistency checks on external datasets.

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

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

• Develop and manage database closure plans, ensuring that closure activities are effectively communicated and executed within the study team.

• Identify and report issues that could impact study timelines or data quality, collaborating with study teams to address these challenges.

• Document Clinical Data Management activities throughout the entire 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.

• A minimum of 5 years of experience as a Clinical Data Manager, with substantial responsibility in clinical projects and study teams.

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

• Proven track record of managing clinical data from study initiation to the declaration of a clean database.

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

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

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

• Solid understanding of relevant clinical research regulations and guidelines, such as ICH and GCP.

• Experience in training and/or mentoring junior Data Management colleagues, with the capability to provide guidance and serve as an escalation point.

• Experience in helping lead global, cross-functional teams towards achieving key study milestones.

• Excellent written and verbal communication skills in English, with fluency in spoken English required.

• Proficient communication skills in the local language.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs that include medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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