Hybrid Senior Data Manager

at OneTrust

• Job title: Senior Data Manager
• Job type: Full Time
• Experience level: Senior
• Salary: $105,000 - $169,050 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Titusville, United States

About the role

• Senior Data Manager at Johnson & Johnson overseeing clinical data management for trials. Leading external partnerships and ensuring compliance with regulatory guidelines within a hybrid work environment.

Responsibilities

• 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).
• 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.

Requirements

• Bachelor's degree (e.g., BS, BA) or equivalent professional experience in Clinical Data Management, Health, or Computer Sciences
• Advanced degrees preferred (e.g., Master, PhD)
• Approximately 4 years of experience in Pharmaceutical, CRO or Biotech industry or related field
• Experience in clinical drug development within the pharmaceutical or related industry
• Experience working with cross-functional stakeholders and teams
• Strong written and verbal communications skills (in English)
• Team leadership experience
• Strong clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols
• In-depth knowledge of current clinical drug development processes
• In-depth knowledge of applicable international guidelines regarding data management of clinical trials
• Knowledge of technology platforms and systems to capture and process data
• Knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.)
• In-depth knowledge of project management and techniques and knowledge of team management principles

Benefits

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• long-term incentive program
• vacation - up to 120 hours per calendar year
• sick time - up to 40 hours per calendar year; up to 56 hours for employees in Washington State
• holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year