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- Tasks: Lead study start-up activities and ensure timely project delivery in compliance with regulations.
- Company: Join Novartis, a diverse and inclusive employer committed to making a difference.
- Benefits: Enjoy competitive rewards, professional growth, and a supportive community.
- Other info: Collaborative environment with opportunities for personal and professional development.
- Why this job: Make a real impact on patients' lives through innovative clinical trials.
- Qualifications: Degree in health/science and experience in clinical operations or project management.
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.
Summary
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.
About the Role
Key responsibilities but not limited to:
- 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.
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. Ready to create a brighter future together?
Benefits and Rewards:
Learn about all the ways we'll help you thrive personally and professionally.
SSO Study Start-Up Manager employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land SSO Study Start-Up Manager
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those connected to Novartis. Attend events, join online forums, and don’t be shy about asking for informational interviews. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by researching Novartis and their projects. Understand their values and how they align with your own. Practice common interview questions and think of examples from your experience that showcase your skills in clinical operations and project management.
✨Tip Number 3
Follow up after interviews! A simple thank-you email can go a long way. It shows your appreciation and keeps you fresh in the interviewer's mind. Plus, it’s a great opportunity to reiterate your enthusiasm for the role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we often have exclusive roles listed there that you won’t find anywhere else. So, keep an eye out and get your applications in!
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 relevant experience in clinical operations and project management, and don’t forget to showcase your understanding of trial set-up and execution.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role at Novartis and how your skills align with their mission. Keep it concise but impactful!
Showcase Your Soft Skills: Don’t just focus on technical skills; highlight your interpersonal, negotiation, and conflict resolution abilities. These are crucial for collaborating in a matrix environment, so make sure they stand out!
Apply Through Our Website: We encourage you to apply through our website for the best chance of success. It’s the easiest way for us to keep track of your application and ensure it gets the attention it deserves!
How to prepare for a job interview at Novartis
✨Know Your Stuff
Make sure you understand the ins and outs of clinical trial processes, especially around study start-up activities. Brush up on GCP/ICH guidelines and Novartis' specific protocols. This will show that you're not just interested in the role but also knowledgeable about what it entails.
✨Show Your Collaborative Spirit
Since this role involves working closely with various teams, be ready to discuss your experience in collaborative environments. Share examples of how you've successfully partnered with others to meet project goals, particularly in a matrixed setting.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in previous roles, especially related to study start-up or regulatory submissions, and how you overcame them. This will demonstrate your critical thinking and adaptability.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions prepared. Inquire about the team dynamics, the biggest challenges they face in study start-up, or how success is measured in this role. This shows your genuine interest and helps you gauge if the company culture aligns with your values.