SUMMARY

LI-Hybrid

Location: East Hanover, NJ
This key role will use advanced data management tools and techniques, provide professional and lean execution of Data Management products and milestones with respect to cost, quality and timelines for all assigned trials within Clinical Data Acquisition and Management. In addition, they will ensure consistently high-quality data delivery (in alignment with the Novartis Clinical Data Quality Statement) to analysis and reporting.

MINIMUM REQUIREMENTS:

• BA/BS in life science, computer science, nursing or closely related degree
• 4 years’ experience in Drug Development with at least 3 years’ in Clinical Data Management
• Proven ability to interrogate and view data though various programming/GUI techniques
• 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 stakeholder
• Demonstrated problem-solving skills
• Excellent verbal and written skills

PREFERRED QUALIFICATIONS:

• Oncology experience, particularly in Early Development Oncology
  The salary for this position is expected to range between $94,000 and $174,000 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.
  Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
  Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
  Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

KEY RESPONSIBILITIES:

• Provide DM leadership across assigned trial(s) Acts as the Trial Data Scientist where needed ensuring strong DM representation across the CTT.
• Demonstrate a business understanding of the compound(s) profile and data strategy to identify and assist in successful application of data management processes and documentation across assigned trials, 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.
• Provides accelerated feedback to assure well written, stable protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting, minimize the data footprint to focus on the trial endpoints and ensures utilization of available data standards.
• Perform DM activities for study start up including preparing the architecture of the eCRF, CCG’s, Data Quality Plan (DQP), Data Quality Plan Module (DQPM), Data Transfer Specification (DTS) and performing user acceptance testing (UAT)
• Manage local lab data flow and set up for the Clinical Database as applicable
• Performs DM hands on activities during the course of the study, with a strong emphasis on quality, integrity and on-time delivery.