Clinical Data Management Lead

4 days ago

East Hanover, New Jersey, United States Novartis Full time
Job Description

Job Title: Clinical Data Management Lead

Location: East Hanover, NJ

About the Role:

We are seeking a highly skilled Clinical Data Management Lead to join our team at Novartis. As a key member of our organization, you will be responsible for managing all Data Management deliverables at a consistently high standard with respect to cost, quality, and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s).

Your Key Responsibilities:

  • Provide DM leadership across assigned trial(s) and Program(s) ensuring strong DM representation across the CTT.
  • Act as an ambassador for CDAM across the organization, showcasing business value and benefits.
  • Demonstrate a business understanding of the compound profile and data strategy to identify and assist in successful application of consistent data management processes and documentation across assigned programs.
  • Ensure 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.
  • Maintain awareness of the status of start-up, conduct and finalization activities for all trials within assigned program(s).
  • Track and request necessary resources.
  • Ensure the key study risks & issues are shared in the Project Review Meeting led by Sr GHs/GHs.
  • Provide accelerated feedback to assure well written, stable protocols and amendments.
  • Recognize and resolve protocol issues that may impact database.

Essential Requirements:

  • Bachelor's degree in life science, computer science, pharmacy, nursing or closely related discipline.
  • 7 years' experience in Drug Development with at least 5+ years' in Clinical Data Management.
  • Demonstrated 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.
  • Understanding of project management concepts in order to aid delivery across a program.

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. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Benefits and Rewards:

We offer a comprehensive benefits package that includes medical, financial, and other benefits to support your physical, emotional, and financial well-being. Our benefits and rewards program is designed to help you thrive personally and professionally.

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