Senior Clinical Data Science Lead

This is a fully remote position, open to applicants in United Kingdom, +3 more countries.

📋 Description

• Supervise clinical data management activities throughout the study lifecycle, ensuring that deliverables meet quality, compliance, and timeline standards.

• Manage daily clinical data management tasks for assigned studies and oversee CROs and external vendors, including laboratories, ECG providers, and imaging companies.

• Assess vendor performance, timelines, and key performance indicators (KPIs), proactively identifying and addressing data-related risks.

• Review and authorize study documentation, such as Data Management Plans (DMPs), CRF/eCRF specifications, Data Validation Plans (DVPs), database specifications, and Data Transfer Agreements (DTAs).

• Engage in User Acceptance Testing (UAT) for Electronic Data Capture (EDC) systems, ensuring that database functionality aligns with protocol requirements.

• Oversee data quality evaluations, reconciliation activities, query management, medical coding, safety data reconciliation, data cleaning, readiness for database lock, and final data transfers.

• Coordinate clinical data management timelines to facilitate key study milestones, including interim data cuts, analyses, and final database locks.

• Collaborate with cross-functional study teams and external partners to ensure adherence to ICH-GCP guidelines, FDA/EMA regulations, and relevant standard operating procedures.

• Facilitate study-related meetings with sponsors and vendors, ensuring clear communication and alignment among all stakeholders.

⛳️ Requirements

• Bachelor's degree in a scientific, life sciences, healthcare-related, or equivalent field.

• At least 5 years of experience in clinical data management supporting multicenter clinical trials within the pharmaceutical, biotechnology, or CRO sectors.

• Proven experience in a sponsor environment or managing sponsor relationships via a CRO partnership model.

• Proficiency with leading EDC platforms such as Medidata Rave, Oracle InForm, or Veeva Vault CDMS.

• Strong knowledge of CDISC standards, medical coding dictionaries (MedDRA and WHO-DD), and data reconciliation processes.

• In-depth understanding of ICH-GCP guidelines, 21 CFR Part 11 requirements, and best practices in clinical data management.

• Exceptional communication, stakeholder management, and vendor oversight abilities, with a capacity to influence outcomes across interdisciplinary teams.

• Strong analytical and problem-solving skills, with a proven history of identifying and resolving complex data issues and study risks.

• Proficiency in English, both written and spoken.

• Programming knowledge is a plus.

• Previous experience in tobacco or nicotine-related clinical studies and familiarity with EU clinical regulations would be advantageous.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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