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Study Start Up Director

4 months ago

Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

#LI Field BasedThe Study Start-Up (SSU) Director plans and performs global SSU activities to ensure timely trial document and task completion to enable country Health Authority (HA) submission and site activation to meet bold recruitment plans.You will lead the SSU delivery sub-team of the CTT, 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.In addition, you may take on additional line management responsibilities leading a community of practice for 8-10 SSU Leads, supporting associate development, training, culture building, resourcing and performance management tasks or other key initiatives.

About the Role

Key Responsibilities:

Aligns the SSU plan and strategy accordingly as reflected in SSU systems, landmarks, and dashboards with Study Leader/Clinical Trial Team (CTT).

Configures and ensures proper trial-specific set-up of SSU systems (e.g., Expected Document Lists, eTMF, landmarks, tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS, enrollment plan, vendor management tool, site contracting and budgeting tool, ICF template tool, etc.)

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.

Manages critical path to ensure timely collection of trial level document readiness (including vendor and IMP) into eTMF as necessary for country health authority submission and site activation.

Drives clarity of timelines of global SSU deliverables with SSU Managers to ensure country alignment and efficiency.

Global accountability of timelines, accuracy, and quality of global TMF (Trial Master File) documents in study start-up to ensure TMF inspection readiness.

Provide 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.

Ensures proper hand-off of activities applicable to the Study Leader and other roles as necessary.

Ensure global deliverables to enable site initiation readiness is in place for initial drug release.

Ensures global and country budget (TCF) processes and approvals support SSU activities

Fluent English, spoken and written.

A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management, is preferable.

Proven experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials with experiene of people management experience in some aspect of conducting clinical trials in pharmaceutical industry or a contract research organization.

Proven ability to actively engage and lead associates from varying backgrounds and functions within dispersed and highly matrixed organizations along with excellent communication, influencing and negotiating skills along with being data and timeline driven.

Good knowledge of Good Clinical Practice, clinical trial set-up design and global drug development process.

Data and Digital expertise. Experience working with electronic databases, clinical and/or project management planning and reporting and analytics systems.

Proven record of accomplishment in process improvement.

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:

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.

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 here:

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?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Division Development

Business Unit Pharmaceuticals

Location Ireland

Site Dublin (Novartis Global Service Center (NGSC))

Company / Legal Entity IE02 (FCRS = IE002) Novartis Ireland Ltd

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