Prin Clinical Data Manager

Job Description Summary

Job Description

Location: East Hanover, NJ
#LI-Hybrid (cannot be done remotely)

Internal job title: Principal Clinical Data Scientist
Hiring for multiple roles.

Your Key Responsibilities:
* Provide DM leadership across assigned trial(s) and Program(s) ensuring strong DM representation across the CTT. Acts 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, i.e. ensuring consistency across data quality plans
* 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. Ensures consistency of program level standards
* Maintain awareness of the status of start-up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Ensures 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.
* 5 years' experience in Drug Development with at least 3+ 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

Preferred Qualifications:

• 4 years' Oncology experience, particularly in Early Development Oncology
• Previous experience in pharma

The salary for this position is expected to range between $114,000 and $211,000 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired