Analyst II, Global Data Manager
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: Spring House • New Jersey • Pennsylvania • United States
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Salary
💰 $92,000 - $148,350 per year
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.
- 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
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Applicant Tracking System Keywords
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Hard Skills & Tools
clinical data managementdata managementeCRFdata collection toolsdataset contentdataset structureregulatory compliancedata management deliverablesclinical drug developmentoversight controls
Soft Skills
leadershipcommunicationorganizationclarityaccuracyteam collaborationproblem-solvingprocess improvementstakeholder engagementtime management
Certifications
Bachelor's degreeBSBA