At a Glance
- Tasks: Support clinical studies by reviewing data and generating insights for patient safety.
- Company: Join Novartis, a leader in healthcare with a commitment to diversity and inclusion.
- Benefits: Enjoy competitive salary, health insurance, flexible working, and 25 days annual leave.
- Other info: Hybrid working environment with opportunities for personal and professional growth.
- Why this job: Make a real impact on patients' lives while collaborating with passionate professionals.
- Qualifications: Advanced degree in Life Sciences and experience in clinical research required.
The predicted salary is between 50000 - 65000 £ per year.
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Work Arrangement: Hybrid Working, Location: London (The Westworks), United Kingdom. Relocation Support: This role is based in London, United Kingdom. Novartis is unable to offer relocation support: please only apply if accessible.
ABOUT THE ROLE
The Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The CSE I is a core member of the Integrated Clinical Trial Team (iCTT) and may support program level activities as assigned.
Key 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.
Essential Requirements
- 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 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.
Desirable Requirements
- Experience contributing to regulatory documents (e.g., CSRs, Investigator's Brochures, submissions).
- Exposure to pharmacovigilance activities and safety data review.
- Experience with innovative data analytics tools and visualization platforms.
- Previous experience supporting global clinical trials.
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives.
You'll receive: Competitive salary, Short term incentive bonus, Pension scheme, Health insurance, 25 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.
Clinical Scientific Expert (CSE) I employer: Novartis
Novartis is an exceptional employer that fosters an inclusive and collaborative work environment, particularly in its London location. With a strong commitment to employee growth, Novartis offers competitive salaries, flexible working arrangements, and extensive learning opportunities, ensuring that every team member can thrive both personally and professionally while contributing to meaningful advancements in healthcare.
