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- Tasks: Lead study start-up activities and ensure timely project delivery in compliance with regulations.
- Company: Join Novartis, a global leader in healthcare innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic work environment with strong emphasis on collaboration and career advancement.
- Why this job: Make a real impact in clinical trials and contribute to groundbreaking healthcare solutions.
- Qualifications: Degree in a scientific or health discipline; experience in clinical operations 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 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.
Skills Desired: Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model.
SSO Study Start-Up Manager in London employer: Novartis
Contact Detail:
Novartis Recruiting Team
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 professionals in the clinical operations field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that SSO Study Start-Up Manager role.
✨Tip Number 2
Prepare for interviews by researching Novartis and their study start-up processes. We recommend practising common interview questions related to project management and clinical trials, so you can showcase your expertise confidently.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can keep you fresh in the interviewer’s mind. We believe this small gesture shows your enthusiasm for the role and helps build rapport.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who take the initiative to connect with us directly.
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 Soft Skills: Don’t just focus on technical skills; we want to see your interpersonal and negotiation skills too! Share examples of how you've successfully navigated challenges in a matrix environment or resolved conflicts in previous roles.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive 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 brush up on the specifics of clinical operations and study start-up processes. Familiarise yourself with GCP/ICH guidelines and Novartis processes, as these will likely come up during your interview.
✨Show Your Collaboration Skills
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 any experiences where you led projects or coordinated with multiple stakeholders.
✨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 respond to deficiency letters or manage timelines under pressure, and be ready to discuss those situations.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the role and the company. Inquire about the team dynamics, current projects, or how success is measured in the SSO Study Start-Up Manager position.