Senior Clinical Data Science Lead

Location: Remote within Ireland, South Africa, Spain, or the United Kingdom

Company

hirify.global Strategic Solutions provides sponsor-dedicated clinical research and data management services through its global FSP organisation.

What you will do

• Lead clinical data management activities across the full study lifecycle for assigned multicentre studies.
• Oversee CROs and external vendors, monitoring performance, timelines, KPIs, and data-related risks.
• Review and approve Data Management Plans, CRF/eCRF specifications, Data Validation Plans, database specifications, and Data Transfer Agreements.
• Participate in EDC User Acceptance Testing and ensure database functionality meets protocol requirements.
• Oversee data quality review, reconciliation, query management, medical coding, safety data reconciliation, cleaning, database lock readiness, and final data transfers.
• Lead sponsor and vendor meetings while coordinating cross-functional teams and maintaining ICH-GCP and regulatory compliance.

Requirements

• Bachelor’s degree in a scientific, life sciences, healthcare-related, or equivalent discipline.
• At least 5 years of clinical data management experience in pharmaceutical, biotechnology, or CRO environments.
• Experience supporting multicentre clinical studies in a sponsor environment or through a CRO partnership model.
• Expertise with Medidata Rave, Oracle InForm, or Veeva Vault CDMS; programming knowledge is desirable.
• Knowledge of CDISC standards, MedDRA and WHO-DD dictionaries, data reconciliation, ICH-GCP, and 21 CFR Part 11.
• Fluent English, written and verbal, is required. Strong stakeholder management, vendor oversight, analytical, and problem-solving skills are also required.

Nice to have

• Experience with tobacco or nicotine-related clinical studies.
• Knowledge of EU clinical regulations.
• Programming experience.

Culture & Benefits

• Collaborative, inclusive environment focused on high-quality clinical research.
• Annual leave entitlements and country-specific health insurance options.
• Retirement planning, life assurance, and a global employee assistance programme.
• Flexible country-specific benefits, including childcare vouchers, gym memberships, travel passes, and health assessments.