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Study Start Up Senior Lead

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Novartis

11d ago

  • Job
    Full-time
    Senior Level
  • Consulting
    Research & Development
  • Dublin

AI generated summary

  • You need a degree in a scientific/health discipline, 6 years in project management, 3 years in clinical trials, strong team leadership, and excellent problem-solving skills. Fluent English is essential.
  • You will oversee all SSU activities for complex studies, ensuring trial setup, document readiness, and site activation, while coaching team members and managing timelines and quality.

Requirements

  • - A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management, is preferable
  • - Minimum 6 years' experience in project management, in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
  • - Minimum 3 years of 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
  • - Fluent English, spoken and written
  • - Proven ability and strong experience in leading multidisciplinary teams in a complex matrix environment (including remote or virtual team environments)
  • - High learning agility championing new technology platforms
  • - Strong problem solving, negotiation, deadline driven and conflict resolution skills

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 aligns the SSU plan and strategy accordingly as reflected in SSU systems, milestones 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, milestones, tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS (Clinical Trial Management System), enrollment plan, vendor management tool, site contracting and budgeting tool, ICF template tool, etc.)
  • Autonomously strategizes global SSU planning and leads SSU Team (CTT sub-team) from kick-off through completion of SSU (all countries and 95% sites enrolling or as defined per trial).
  • 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 Committee submission and site activation.
  • Global accountability of timelines, accuracy, and quality of global TMF (Trial Master File) documents in study start-up to ensure TMF inspection readiness.
  • Coaches the country Study Start-up Managers to drive timely start-up activities from country allocation to “Ready to Enroll” within assigned medium to complex trials.
  • 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.
  • Ensure global deliverables to enable site initiation readiness is in place for initial drug release.

FAQs

What are the main responsibilities of the Study Start-Up Senior Lead?

The main responsibilities include leading all Study Start-Up activities for complex global studies, ensuring timely trial document completion for Health Authority submissions, overseeing the SSU Team, and strategizing global SSU planning.

What qualifications are required for this position?

A degree in a scientific or health discipline is required, with an advanced degree and clinical trial experience preferred. A minimum of 6 years in project management within clinical operations is also necessary.

Is there a requirement for leadership experience?

Yes, proven experience in leading multidisciplinary teams in a complex matrix environment is necessary, along with strong problem-solving and conflict resolution skills.

In which location is this position based?

The position is based in Dublin, Ireland, at the Novartis Corporate Center, with alternative locations available in India and the United Kingdom.

Does this role involve direct reports?

No, the Study Start-Up Senior Lead does not have direct reports; instead, they operate as a matrix team leader.

What is the expected team size that the Study Start-Up Senior Lead will manage?

The SSU Team comprises 20+ members across multiple countries.

How many years of experience in clinical trials is required?

A minimum of 3 years of contribution to all aspects of conducting clinical trials in a global/matrix environment is required.

Is fluency in English necessary for this role?

Yes, fluent English, both spoken and written, is a requirement for this position.

What kind of working environment does Novartis promote?

Novartis is committed to building an outstanding, inclusive work environment and diverse teams that represent the patients and communities they serve.

What benefits and rewards does Novartis offer?

Novartis offers a comprehensive range of benefits and rewards, which can be reviewed in the Novartis Life Handbook available on their careers website.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world.

Culture & Values

  • Inspired

    Engage our people. Strive for patients. Live our purpose

  • Curious

    Learn. Be open. Be self-aware

  • Unbossed

    Create clarity. Serve others. Own your actions

  • Integrity

    Be honest. Have courage. Do what’s right