Hybrid Analyst II, Global Data Manager

at OneTrust

• Job title: Analyst II, Global Data Manager
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: $92,000 - $148,350 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Spring House, United States

About the role

• Analyst II Data Manager responsible for overseeing data management activities for clinical trials. Collaborating with partners to ensure data integrity and compliance in healthcare innovation.

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.
• Review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
• Ensure compliance with regulatory guidelines and the documentation matrix.
• Ensure real-time inspection readiness of all DM deliverables for the trial and participate in regulatory agency and J&J internal audits as necessary.
• Plan and track content, format, quality, and timing of applicable data management deliverables.
• Ensure deliverables are on time.
• Take a leadership role with the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are achieved.
• Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
• Identify and communicate lessons learned, best practices, and frequently asked questions at the trial level.
• Identify and participate in process, system, and tool improvement initiatives.
• Perform trial level oversight controls and/or execute data management activities per applicable procedures, with DML direction.

Requirements

• Minimum of Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences is required.
• Minimum of 2 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
• Experience in clinical drug development within the pharmaceutical industry or related industry.
• Experience working with cross functional stakeholders and teams.
• Strong written and verbal communications skills (in English).

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))
• annual performance bonus
• vacation – 120 hours per calendar year
• sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year