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Study Start Up Senior Lead (Associate Director)

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Novartis

19d ago

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

AI generated summary

  • You need a degree in a health/science field, 6+ years in project management, 3+ years in clinical trials, fluent English, and strong leadership, problem-solving, and negotiation skills.
  • You will manage Study Start-Up activities, ensuring trial setup, document readiness, and site activation while leading teams and maintaining timelines for smooth study execution.

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 is the job title for this position?

The job title is Study Start Up Senior Lead (Associate Director).

Where is this position located?

The position is located in Dublin, Ireland, with alternative locations in Hyderabad, India, and London, United Kingdom.

What are the primary responsibilities of the Study Start Up Senior Lead?

The primary responsibilities include independently leading global SSU activities for multiple medium to complex global studies, managing timelines, ensuring document readiness for Health Authority and Ethics Committee submissions, and overseeing the SSU Team.

Is this position office-based or remote?

This position is hybrid, meaning associates are expected to work from the office in London or Dublin for 9 – 12 days per month.

What qualifications are required for this role?

A degree in a scientific or health discipline is required, with an advanced degree preferred. Additionally, at least 6 years of experience in project management within clinical operations is necessary.

What languages are required for this position?

Fluency in English, both spoken and written, is required for this position.

What is the team structure for this role?

The Study Start Up Senior Lead leads a matrix team of 20+ members across multiple countries, including country SSU Management, Vendor Management, Regulatory, Grants and Contracts, and more, but does not have direct reports.

What are the expected working hours for this position?

This position is full-time, and specific working hours may vary; however, it does not require shift work.

What kind of environment does Novartis promote?

Novartis promotes an outstanding, inclusive work environment with diverse teams representing the patients and communities served.

What benefits does Novartis offer?

Novartis provides various benefits and rewards, which can be found detailed in the Novartis Life Handbook.

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