Prin Clinical Data Manager

Role Summary

Principal Clinical Data Scientist responsible for managing all Data Management deliverables with respect to cost, quality, and timelines for assigned indications within Global Clinical Program(s)/Project(s). Location: East Hanover, NJ (no remote work).

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

Qualifications

• Bachelor‚Äôs degree in life science, computer science, pharmacy, nursing or closely related discipline.
• 5 years‚Äô 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

Skills

• Leadership
• Data Management
• CDISC standards
• Program management
• Risk identification and mitigation

Education

• Bachelor‚Äôs degree as specified in Qualifications

Additional Requirements

• On-site role in East Hanover, NJ; candidate must be able to work in the specified location