At a Glance
- Tasks: Lead study start-up activities and ensure timely project deliverables in clinical trials.
- Company: Join a global leader in healthcare innovation with a commitment to improving patient outcomes.
- Benefits: Competitive salary, health benefits, flexible working options, and opportunities for professional growth.
- Other info: Dynamic work environment with excellent career advancement opportunities.
- Why this job: Make a real impact in clinical research while collaborating with diverse teams worldwide.
- Qualifications: Degree in a scientific field; experience in clinical operations or project management preferred.
The predicted salary is between 50000 - 65000 € per year.
The SSO Study Start‑Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team. In satellite countries acts as primary back‑up and deputy of the country manager.
Key Responsibilities
- Support country SSU strategy in close collaboration with SSO Study Start‑Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio.
- Collaborate with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments.
- Accountable for timely start‑up activities from country allocation until Green Light (ready to initiate site milestone) in assigned projects.
- Ensure close collaboration with local IRBs/IECs and Health Authorities as applicable.
- Ensure that study start‑up activities are conducted and completed on time, including preparation and review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required.
- Prepare and finalise local submission package for submission to IRB/IEC, CTA Hub (Europe: according to new EU‑CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs).
- Coordinate timely response to deficiency letters in close collaboration with local and global stakeholders.
- Coordinate reportable events and notifications to IRB/IEC and Health Authorities, e.g. substantial and non‑substantial amendments, IB updates, ICF updates as applicable, including preparation, update, and review of submission documents.
- Accountable for timelines, accuracy, and quality of country TMF documents in study start‑up to ensure TMF inspection readiness.
Essential Criteria
- A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable.
- Strong experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials.
- Capable of leading in a matrix environment, without direct reports.
- Understanding of all aspects of clinical drug development with particular emphasis on trial set‑up, execution, and monitoring.
Desirable Criteria
- Strong interpersonal, negotiation and conflict resolution skills.
- Communicates effectively in a local/global matrixed environment.
SSO Study Start-Up Manager in London employer: Novartis UK
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation. As an SSO Study Start-Up Manager, you will benefit from comprehensive employee growth opportunities, including professional development and training tailored to enhance your clinical operations expertise. Our commitment to compliance and quality ensures that you will be part of a team dedicated to making a meaningful impact in the healthcare sector, all while enjoying the advantages of working in a supportive environment that values your contributions.
StudySmarter Expert Advice🤫
We think this is how you could land SSO Study Start-Up Manager in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and role thoroughly. Understand their values and how your experience aligns with their needs. Practise common interview questions and have your own ready to show your interest.
✨Tip Number 3
Follow up after interviews! A simple thank-you email can go a long way. It shows your enthusiasm for the role and keeps you fresh in their minds as they make their decision.
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Don’t forget to apply through our website! We’ve got loads of opportunities that might be perfect for you. Plus, it’s a great way to ensure your application gets seen by the right people.
We think you need these skills to ace SSO Study Start-Up Manager in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the SSO Study Start-Up Manager role. Highlight your experience in clinical operations and project management, and don’t forget to mention any relevant qualifications or skills that match the job description.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention specific experiences that demonstrate your ability to manage study start-up activities and collaborate with global teams.
Showcase Your Teamwork Skills:Since this role involves close collaboration with various stakeholders, make sure to highlight your teamwork and communication skills. Share examples of how you've successfully worked in a matrix environment to achieve project goals.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s straightforward, and you’ll be able to submit all your documents in one go. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at Novartis UK
✨Know Your Stuff
Make sure you brush up on the specifics of clinical trial processes and regulations, especially GCP/ICH guidelines. Familiarise yourself with Novartis' approach to study start-up activities so you can speak confidently about how your experience aligns with their expectations.
✨Show Your Collaborative Spirit
Since this role involves working closely with various teams, be ready to share examples of how you've successfully collaborated in a matrix environment. Highlight your interpersonal skills and any experiences where you’ve led projects or resolved conflicts effectively.
✨Be Ready for Scenario Questions
Prepare for questions that ask how you would handle specific challenges related to study start-up activities. Think about potential issues with local IRBs/IECs or Health Authorities and how you would ensure timely responses and compliance.
✨Demonstrate Your Organisational Skills
This role requires managing multiple timelines and deliverables. Be prepared to discuss how you keep track of tasks and ensure accuracy in documentation, particularly regarding TMF inspection readiness. Share any tools or methods you use to stay organised.
