At a Glance
- Tasks: Support clinical studies by reviewing data and generating insights for patient safety.
- Company: Join Novartis, a leader in healthcare innovation with a commitment to diversity.
- Benefits: Enjoy competitive salary, health insurance, flexible working, and 25 days annual leave.
- Other info: Hybrid working model with excellent learning and development opportunities.
- Why this job: Make a real impact in clinical research while developing your skills in a dynamic environment.
- Qualifications: Advanced degree in Life Sciences and experience in clinical research required.
The predicted salary is between 55000 - 65000 £ per year.
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.
Benefits
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 in London employer: Novartis UK
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic hybrid working environment in the heart of London. Our commitment to employee growth is reflected in our comprehensive learning and development opportunities, alongside competitive benefits such as a pension scheme and health insurance. Join us to be part of a diverse team that values collaboration and innovation, ensuring that your contributions directly impact patient safety and clinical excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Scientific Expert (CSE) I in London
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We think you need these skills to ace Clinical Scientific Expert (CSE) I in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Novartis UK!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Novartis UK that you're not just a fit for the job but also a safety-conscious candidate!
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How to prepare for a job interview at Novartis UK
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Novartis UK that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
