Clinical Study Data Lead

Role Overview

This position is located in Dublin, Ireland, requiring hybrid work with an expectation of 12 onsite days per month. Visa sponsorship is not provided for this or related roles in London, Barcelona, and East Hanover. Candidates should note that relocation support is unavailable.

Role Summary

The Clinical Study Data Lead contributes as a strategic partner within Clinical Data Operations in Global Clinical Operations. The role drives the clinical data strategy for multiple complex trials, ensuring the delivery of high-quality and submission-ready clinical data that accelerates patient-centric decision-making.

Responsibilities

• Lead data management activities across multiple trials, overseeing timely, compliant, and quality data deliverables.
• Develop and implement trial-specific data strategies aligned with regulatory, program, and data standards.
• Manage end-to-end data flow including collection, database design, quality control, and database lock preparation.
• Serve as Clinical Data Management representative in governance and quality forums, facilitating data-related decisions and swift resolution of issues.
• Proactively identify data risks and dependencies, applying mitigation strategies, root cause analysis, and escalating as required.
• Maintain audit readiness through strict Quality by Design processes and adherence to standards across assigned trials.
• Disseminate lessons learned and best practices to enhance consistent data quality and trial portfolio improvement.

Distinctive Role Features

• Accountable for comprehensive clinical data strategy and execution for multiple trials, ensuring portfolio-wide consistency.
• Combines operational execution with strategic decision-making, influencing clinical data governance forums.
• Leads cross-functional teams and guides Principal Study Data Leads without direct reporting lines.
• Contributes to data-related protocol development, dataflow setup, timely database locks, and regulatory submissions.
• Emphasizes quality, compliance, and inspection readiness in regulatory environments.

Candidate Profile

• Bachelor's degree or equivalent in life sciences, computer science, or relevant discipline; postgraduate qualifications are advantageous.
• Minimum 5-8 years of clinical data management experience in regulated R&D settings, demonstrating trial data strategy leadership.
• Strong knowledge of clinical trial methodology, Good Clinical Practice (GCP), and medical terminology.
• Advanced data analysis and data-driven decision-making skills with critical thinking capability.
• Proven leadership and collaboration abilities in global, cross-functional teams.
• Competence in risk identification, problem-solving, and implementation of effective data management solutions.
• Excellent communication and stakeholder influencing skills.
• Experience mentoring peers and supporting team success.

Compensation and Benefits

The annual base salary for this role ranges from €55,370 to €102,830, determined using gender-neutral criteria based on skills, experience, and competencies and reviewed regularly. Additional eligibility for performance-based bonuses exists.

Benefits encompass various insurance and retirement plans, wellbeing resources, global recognition programs, flexible and hybrid work arrangements, and at least 14 weeks of paid parental leave.

Novartis is committed to pay equity, diversity, inclusion, and maintaining a respectful workplace ethics code.

Additional Information

Applicants should note no relocation support or visa sponsorship is offered. Employment details, including collective bargaining agreement applicability, will be communicated during the recruitment process.