Job Description Summary

The SSO Study Start-Up Manager is accountable for study planning, study start-up 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.

Hybrid working (12 days per month in the office)

#LI Hybrid
#LI-HYBRID

Job Description

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 commitments
Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) 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)
Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness
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
Oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution
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

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! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and 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.

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Skills Desired

Budget Management, Clinical Trials, Negotiation, Process Improvements, Project Planning, Vendor Management, Waterfall Project Management