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 60000 - 80000 € 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 employer: Novartis UK
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation. As a SSO Study Start-Up Manager, you will benefit from comprehensive professional development opportunities, competitive compensation, and the chance to make a meaningful impact in the healthcare sector. Our commitment to employee well-being and growth, combined with our global presence, makes Novartis an ideal place for those seeking a rewarding career in clinical operations.
StudySmarter Expert Advice🤫
We think this is how you could land SSO Study Start-Up Manager
✨Network Like a Pro
Get out there and connect with people in the industry! Attend events, join online forums, and don’t be shy about reaching out to professionals on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Ace the Interview
Prepare for your interviews by researching the company and the role inside out. We recommend practising common interview questions and even doing mock interviews with friends. Show them your passion for the SSO Study Start-Up Manager role and how you can contribute to their success!
✨Follow Up
After your interview, don’t forget to send a thank-you email! It’s a great way to show your appreciation and reiterate your interest in the position. We believe this small gesture can make a big difference in keeping you top of mind for the hiring team.
✨Apply Through Our Website
Make sure to apply directly through our website for the best chance at landing the job. We keep our listings updated and it shows your commitment to joining our team. Plus, it’s super easy to navigate and submit your application!
We think you need these skills to ace SSO Study Start-Up Manager
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 super easy, and you’ll be able to keep track of your application status directly!
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 times when you had to coordinate with local IRBs or manage timelines under pressure, and be ready to discuss these scenarios in detail.
✨Demonstrate Your Attention to Detail
This role requires accuracy in documentation and compliance. Bring examples of how you've ensured quality and inspection readiness in previous projects. Discuss your methods for maintaining meticulous records and how you handle submission packages to regulatory bodies.
