At a Glance
- Tasks: Support clinical studies by reviewing data and generating insights for patient safety.
- Company: Join Novartis, a leader in innovative healthcare solutions.
- Benefits: Enjoy competitive salary, health insurance, flexible working, and 25 days annual leave.
- Other info: Be part of a diverse team committed to excellence and innovation.
- Why this job: Make a real impact on patients' lives through groundbreaking clinical research.
- Qualifications: Advanced degree in Life Sciences and experience in clinical research required.
The predicted salary is between 54000 - 66000 £ per year.
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 (i CTT) 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 i CTT 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, Pharm D, MPharm, Ph D, 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 Gx P 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
- 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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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Clinical Scientific Expert I London employer: Meeveem Limited
Meeveem Limited is an excellent employer for general practitioners, offering a supportive and flexible work environment that prioritises professional growth and work-life balance. With full indemnity cover, NHS Pension, and generous leave, our team members enjoy a culture of collaboration and continuous development across our two sites, making it an ideal place for those seeking meaningful and rewarding employment.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Scientific Expert I London
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We think you need these skills to ace Clinical Scientific Expert I London
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at Meeveem Limited.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at Meeveem Limited.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to Meeveem Limited. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at Meeveem Limited. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at Meeveem Limited
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
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Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research Meeveem Limited’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
