The Senior Data Manager is a professional individual contributor role at experienced level that provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity trials

• The Senior Data Manager makes recommendations and decisions that have an impact on processes, timing, and structure for trials and assignments with minimal direction from manager or Data Management Leader (DML)
• This position also makes recommendations for processes, timing, structure, and resources at a program level
• Work is received in broad terms, reviewed during major deliverables, and the amount of instruction is limited
• Work is reviewed with the Data Management Leaders, or the immediate manager as needed
• You Will Be Responsible For

Take a leadership role with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations to the business for assigned trial(s) to include but not limited to:

• Gather and/or review content and integration requirements for eCRF and other data collection tools
• Establish conventions and quality expectations for clinical data
• Establish expectations for dataset content and structure
• Set timelines and follow-up regularly to monitor delivery of all data management milestones
• Ensure accurate review of related clinical data management documents as well as compliance with regulatory guidelines and documentation requirements
• Ensure real-time inspection readiness of all DM deliverables for the trial; participate in Regulatory Agency and J&J internal audits as necessary
• Lead the planning and tracking of content, format, quality, and timing of applicable data management deliverables
• Ensure deliverables are on time
• Take a leadership role to obtain and share best practices with internal partners
• Identify and communicate lessons learned, best practices and frequently asked questions at the trial level
• Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency
• Identify and participate in process, system, and tool improvement initiatives

Lead others in implementing process, system, and tool improvement initiatives

• We are searching for the best talent for a Senior Data Manager, to be located in Titusville, NJ or Raritan, NJ
• This is a hybrid position and requires you to be onsite 3 days a week

Approximately <10% travel (domestic or international) may be required

• Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences

Advanced Analytics, Clinical Data Management, Clinical Operations, Collaborating, Communication, Database Management, Data Privacy Standards, Data Quality, Data Savvy, Good Clinical Practice (GCP), Innovation, Interdisciplinary Work, Problem Solving, Process Improvements, Research Ethics, Resource Allocation, Training People

• The anticipated base pay range for this position in the US is $105,000 to $169,050
• The Company maintains highly competitive, performance-based compensation programs
• Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan
• The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year
• Bonuses are awarded at the Company’s discretion on an individual basis

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
• This position is eligible to participate in the Company’s long-term incentive program
• Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year