Clinical Data Insight Analyst I

Healthcare Businesswomen’s Association; Dublin; Hybrid; EUR 42,000 - 79,000; Full time

Job summary

Novartis in Dublin, Ireland is seeking a Clinical Scientific Expert I (CSE I) to provide clinical and scientific support across all phases of a study in line with GCP and regulatory requirements.

You will apply data review excellence to identify trends, risks, and data insights, collaborating with cross-functional teams to ensure patient safety, data integrity, and protocol adherence within a hybrid work arrangement.

Qualifications

• Advanced degree in Life Sciences, Healthcare, or a clinically relevant field (e.g., MSc, PharmD, MPharm, PhD, MBBS or equivalent)
• Strong experience in clinical research and clinical trial environments
• Solid understanding of clinical trial protocols and study execution
• Expertise in clinical data review, data integrity, and data quality management
• Experience performing trend analysis and identifying data insights at the patient and study level
• Knowledge of good practice GxP and regulatory requirements applicable to clinical data
• Excellent collaboration skills with the ability to work effectively in cross-functional and matrixed environments
• Strong communication and presentation skills with the ability to convey complex clinical data insights

Responsibilities

• Perform high-quality clinical data review, including patient-level review and trend analysis, to generate actionable insights supporting interim analyses, database lock, and post-lock activities
• Identify, investigate, and facilitate resolution of clinical data issues in collaboration with cross-functional teams, ensuring a strong focus on subject safety, eligibility, and data integrity
• Contribute to the development and execution of Data Review Plans (DRP) / Data Quality Plans (DQP) and associated data review strategies
• Ensure consistent implementation of protocol requirements across studies, including eligibility criteria, study assessments, and protocol deviations
• Collaborate with relevant line functions to enhance data quality review processes, including identification and remediation of trends and anomalies
• Support the development and implementation of Case Report Forms (CRFs) and data capture tools in collaboration with cross-functional partners
• Contribute to continuous improvement of data review processes, including optimization of reports and adoption of innovative analytics tools and methodologies
• Support the development and review of study-level documents, including clinical sections of regulatory submissions, Investigator’s Brochures, clinical study reports (CSRs), and publications
• Participate in pharmacovigilance activities where required, including safety data review, aggregate reports, and Safety Monitoring Team (SMT) meetings
• Develop training materials and deliver training to iCTT members and study teams on data review processes
• Support and present data insights at study-level meetings, including Investigator Meetings and Data Monitoring Committee (DMC) meetings, as required

Skills

Clinical data review

Data quality management

Regulatory knowledge

Trend analysis

Cross-functional collaboration

Communication skills

Pharmacovigilance

Education

Advanced degree in Life Sciences or related

Tools

Data visualization platforms

Job description

Novartis in Dublin, Ireland is seeking a Clinical Scientific Expert I (CSE I) to provide clinical and scientific support across all phases of a study in line with GCP and regulatory requirements.

You will apply data review excellence to identify trends, risks, and data insights, collaborating with cross-functional teams to ensure patient safety, data integrity, and protocol adherence within a hybrid work arrangement.