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- Tasks: Manage study planning and start-up activities for clinical trials.
- Company: Join Novartis, a leader in innovative medicine and inclusive workplace.
- Benefits: Enjoy flexible work options, competitive rewards, and a commitment to diversity.
- Why this job: Be part of a mission to improve lives through groundbreaking research and collaboration.
- Qualifications: Degree in a scientific or health discipline; experience in clinical operations preferred.
- Other info: Opportunity to work with a diverse team and make a real impact.
The predicted salary is between 36000 - 60000 £ 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.
Major Accountabilities:
- Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio.
- Collaborates 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 commitment.
- Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site milestone) in assigned projects.
- Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable.
- Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required.
- Prepares and finalizes local submission package for submission to IRB/IEC, CTA Hub (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs).
- Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders.
- Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable.
- Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness.
- Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
- Implements innovative and efficient processes which are in line with Novartis strategy.
- Supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team.
- Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned.
- In satellite countries oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary.
- Ensures sites are prepared for 'Green Light' and ensures all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site 'Green Light'.
- Oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution, proposing and implementing corrective actions where appropriate, according to Novartis standards and local and international regulations.
- Leads/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as required.
- Leads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU Lead.
Education & Qualifications:
A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable.
Experience:
Experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials.
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.
Accessibility & Accommodation:
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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
Familiarise yourself with Novartis' values and mission. Understanding their commitment to improving lives through innovative medicine will help you align your responses during interviews, showcasing how your personal values resonate with theirs.
✨Tip Number 2
Network with current or former employees of Novartis, especially those in clinical operations or study start-up roles. They can provide valuable insights into the company culture and expectations, which can be beneficial for your interview preparation.
✨Tip Number 3
Stay updated on the latest trends and regulations in clinical trials and study start-up processes. Being knowledgeable about current practices will demonstrate your expertise and commitment to the role during discussions with the hiring team.
✨Tip Number 4
Prepare specific examples from your past experiences that highlight your project management skills and ability to collaborate with diverse teams. This will help you effectively illustrate your qualifications and fit for the SSO Study Start-Up Manager position.
We think you need these skills to ace SSO Study Start Up Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the SSO Study Start-Up Manager position. Understand the key responsibilities and qualifications required, as this will help you tailor your application effectively.
Tailor Your CV: Customise your CV to highlight relevant experience in clinical operations, project management, and any specific skills that align with the job requirements. Use keywords from the job description to ensure your CV stands out.
Craft a Compelling Cover Letter: Write a cover letter that not only introduces yourself but also explains why you are a great fit for the role. Mention specific experiences that demonstrate your ability to manage study start-up activities and collaborate with teams.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial for the role you're applying for.
How to prepare for a job interview at Novartis
✨Understand the Role Thoroughly
Before your interview, make sure you have a solid grasp of the SSO Study Start-Up Manager role. Familiarise yourself with the key responsibilities, such as study planning and compliance with regulatory requirements. This will help you articulate how your experience aligns with the job.
✨Showcase Your Collaborative Skills
Collaboration is crucial in this role, especially with various stakeholders like the SSO Feasibility Manager and global study team. Be prepared to discuss examples from your past experiences where you successfully worked in a team to achieve project goals.
✨Prepare for Regulatory Questions
Given the importance of compliance in clinical operations, expect questions related to GCP/ICH guidelines and local regulations. Brush up on these topics and be ready to demonstrate your knowledge and how you've applied it in previous roles.
✨Demonstrate Problem-Solving Abilities
The role requires implementing innovative processes and proposing corrective actions when necessary. Think of specific instances where you identified issues and successfully resolved them, showcasing your analytical and problem-solving skills.
