Logo of Huzzle

Home

Matches

Explore

Manage

Principal Clinical Data Manager

image

Novartis

14d ago

  • Job
    Full-time
    Expert Level
  • Data
    Research & Development
  • Dublin

AI generated summary

  • You need strong leadership and organizational skills, 9+ years in Drug Development, excellent knowledge of clinical trials, data analysis abilities, and effective communication in a global environment.
  • You will lead data management activities, coordinate data scientists, ensure alignment with data strategies, resolve protocol issues, and maintain relationships with cross-functional teams.

Requirements

  • Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines
  • Excellent understanding of clinical trials methodology, GCP and medical terminology
  • Proven ability to interrogate and view data through various programming/GUI techniques.
  • Must be able to anticipate challenges and risks and proactively suggest/implement solutions
  • Ability to work under pressure demonstrating agility through effective and innovative team leadership
  • Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders
  • Ideally 9+ years’ experience in Drug Development with at least 8 years' in Clinical Data Management
  • Ability to transfer own knowledge to others. Experience as a Trial Data Scientist for several studies and some work performed at a project level

Responsibilities

  • Lead data management activities as Trial Clinical Data Scientist for complex priority trial(s) or as a Project/ Program Clinical Data Scientist for moderate complexity non-priority project(s)/ program in study set up and accountable for all conduct/close out deliverables.
  • Co-ordinate activities of Data Scientist either internally or externally. Make data management decisions and propose strategies at study or project level.
  • Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director.
  • Competent in relevant CDISC or other recognized industry standards and how these impact the programming team. Ensures consistency of program level standards.
  • Provides accelerated feedback to assure well written, stable protocols and amendments aligned with Program standards and requirements.
  • Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting, minimizes the data footprint to focus on the trial endpoints and ensures utilization of available data standards.
  • Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical data management aspects (timelines, scope, resource plan), e.g. as Clinical Data Acquisition & Management representative in study- or project-level team.
  • Review eCRF, assess the need for additional study specific CRF, discuss data structures and review activities and ensure project-level standardization which allows pooling.

FAQs

What qualifications are required for the Principal Clinical Data Manager position?

Candidates should have ideally 9+ years’ experience in Drug Development with at least 8 years' in Clinical Data Management, along with strong leadership, collaboration, and organizational skills.

What are the key responsibilities of this role?

The key responsibilities include leading data management activities for clinical trials, coordinating activities of Data Scientists, ensuring alignment with data strategies, and building effective relationships with cross-functional teams.

Where is this job located?

The Principal Clinical Data Manager position is located in Dublin, Ireland, at the Novartis Corporate Center (NOCC).

Who will this position report to?

This role reports to the Director of Data Management.

Does Novartis offer benefits and rewards for employees?

Yes, Novartis provides various benefits and rewards which can be explored in the Novartis Life Handbook.

What is the company’s commitment to diversity and inclusion?

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

Is this position full-time or part-time?

This is a full-time position.

Are there opportunities for professional development in this role?

Yes, Novartis encourages personal and professional growth, as indicated by their commitment to providing support and resources for employees.

Is prior experience in clinical trials methodology necessary?

Yes, an excellent understanding of clinical trials methodology, GCP, and medical terminology is essential for this role.

How does Novartis approach its purpose and vision?

Novartis aims to reimagine medicine to improve and extend people’s lives, aspiring to become the most valued and trusted medicines company in the world through its dedicated associates.

Novartis

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