Senior Data Manager
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: Titusville • New Jersey • United States
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Salary
💰 $105,000 - $169,050 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical data managementdata management processesproject managementdata collection toolseCRFscientific conceptsclinical trial protocolsregulatory compliancedata management milestonesprocess improvement
Soft skills
leadershipcommunicationteam managementcross-functional collaborationorganizational skillsproblem-solvingbest practices sharingmonitoringtimelinessquality assurance