At a Glance
- Tasks: Lead global study start-up activities and ensure timely trial document completion.
- Company: Join Novartis, a leader in reimagining medicine for better lives.
- Benefits: Enjoy hybrid work, competitive salary, and professional growth opportunities.
- Other info: Diverse and inclusive work environment with excellent career development.
- Why this job: Make a real impact in clinical trials and help improve patient lives.
- Qualifications: Degree in health discipline; project management experience preferred.
The predicted salary is between 60000 - 80000 £ per year.
LOCATION: Westworks London or Dublin: Please apply only if either of these locations are accessible to you, as relocation support is not available.
Hybrid (12 days per month on-site if living within 50 miles of our London office) Remote UK Only (if living beyond 50 miles of our London office)
The Study Start-Up (SSU) Lead plans and executes global SSU activities to ensure timely trial document and task completion to enable country HA (Health Authorities) and Ethics Committee submissions and site activation to meet ambitious recruitment plans. The Study Start-Up Lead works collaboratively with other key CTT members and leads the SSU Team (CTT sub-team) comprised of the country SSU Management, Vendor Management, Regulatory, Grants and Contracts, Translations, Document Management, Clinical Supplies, and others as needed to accelerate study, country, and site activation.
Your Key Responsibilities
- Responsible for all Study Start-Up (SSU) activities for medium to highly complex high priority studies.
- Full responsibility to independently deliver SSU insights to the development of the trial Operational Execution Plan (OEP) and align the SSU plan and strategy accordingly as reflected in SSU systems, milestones and dashboards with Study Leader /Clinical Trial Team (CTT).
- Autonomously strategizes global SSU planning and leads SSU Team (CTT sub-team) from kick-off through completion of SSU.
- Implements global aspects of protocol and OEP amendments, activates and oversees country implementation of amendments as determined per trial and in conjunction with Study Leader.
- Responsible for global trial level document readiness (including vendor and IMP (INVESTIGATIONAL MEDICINAL PRODUCT) and collection into eTMF as necessary for country health authority and Ethics.
- Drives transparency of timelines of global SSU deliverables with SSU Managers to ensure country alignment and efficiency.
- Ensures proactive oversight and risk management for SSU team activities to achieve start-up timelines and quality execution, proposing and implementing corrective actions where appropriate, according to Novartis standards and local and international regulations.
- Provides oversight and support to country Study Start-up Managers as needed to ensure that study start-up activities are conducted and completed to plan, including set-up and usage of tools/systems, timely delivery of SSU deliverables (e.g. IRB/IEC submission packages, Informed Consent review, local submission package for submission to IRB/IEC, CTA (Clinical Trial Application) Hub (Europe: acc. to new EU-CTR) as well as Health Authorities and adherence to process standards.
- Guides the VPM as needed to ensure global vendor activation and site readiness in collaboration with to meet site activation timelines/plan.
- Key contributor and/or Key SME for initiatives or workstreams. May work as Study Start-Up Director deputy to lead SSU community and may provide mentorship/coaching to team member.
Role Requirements
- A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management, is preferable.
- Fluent English, spoken and written.
- Extensive experience in project management, in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials.
- Contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization.
- Proven ability to effectively engage and lead associates from varying backgrounds and functions within dispersed and highly matrixed organizations.
- Comprehensive experience in leading multidisciplinary teams in a complex matrix environment.
Why Novartis
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
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.
Join Our Novartis Network
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network.
Benefits and Rewards
Learn about all the ways we'll help you thrive personally and professionally.
Study Start-up Lead in London employer: Novartis
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic hybrid work environment in vibrant locations like London and Dublin. Our commitment to diversity and inclusion fosters a collaborative culture where employees are empowered to grow through mentorship and leadership opportunities, all while contributing to our mission of reimagining medicine to improve lives. Join us to be part of a team that values your contributions and supports your professional development.
StudySmarter Expert Advice🤫
We think this is how you could land Study Start-up Lead in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about introducing yourself. 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 they align with your own. This will help you answer questions confidently and show that you're genuinely interested in being part of their team.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online platforms to refine your answers. Focus on articulating your experience and how it relates to the Study Start-Up Lead role – this will set you apart from the competition.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search. So, get those applications in and let’s make it happen!
We think you need these skills to ace Study Start-up Lead in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Study Start-Up Lead role. Highlight your experience in clinical trials and project management, and don’t forget to showcase any leadership roles you've had. We want to see how you can bring your unique skills to our team!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background aligns with our mission at Novartis. Keep it engaging and personal – we love to see your personality come through!
Showcase Relevant Experience:When filling out your application, be sure to highlight specific experiences that relate to the responsibilities of the Study Start-Up Lead. Whether it's managing multidisciplinary teams or overseeing complex projects, we want to know how you've made an impact in your previous roles.
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of success. It’s super easy and ensures your application gets to the right people. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Novartis
✨Know Your Stuff
Make sure you understand the key responsibilities of a Study Start-Up Lead. Brush up on your knowledge of clinical trials, project management, and the specific processes involved in study start-up activities. This will help you answer questions confidently and demonstrate your expertise.
✨Show Your Leadership Skills
Since this role involves leading a multidisciplinary team, be prepared to discuss your leadership experiences. Think of examples where you've successfully managed teams or projects, especially in complex environments. Highlight how you engaged with different stakeholders to achieve common goals.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills and ability to manage risks. Prepare by thinking through potential challenges in study start-up processes and how you would address them. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready about the company culture, team dynamics, or specific projects. This shows your genuine interest in the role and helps you gauge if the company is the right fit for you.
