Analyst II, Global Data Manager

About This Role

This role involves overseeing and executing data management activities and performing scientific data review for clinical trials within Johnson & Johnson's Innovative Medicine sector. The Analyst II Data Manager influences decisions and ensures compliance with regulatory guidelines while collaborating with external suppliers and internal teams.

Responsibilities

• Lead discussions with external suppliers, trial customers, and internal partners to align on data management expectations
• Gather and review content and integration requirements for eCRF and other data collection tools
• Establish conventions and quality expectations for clinical data, dataset content, and structure
• Monitor delivery of all data management milestones and ensure timely completion
• Review clinical data management documents for quality, scientific content, organization, clarity, accuracy, format, and consistency
• Ensure real-time inspection readiness of all data management deliverables and participate in regulatory agency and internal audits
• Create key functional plans (e.g., study Integrated Review Plan)
• Identify and communicate lessons learned, best practices, and frequently asked questions
• Identify and participate in process, system, and tool improvement initiatives
• Perform trial level oversight controls and/or execute data management activities per applicable procedures

Requirements

• 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)

Qualifications

• Bachelor's degree (e.g., BS, BA) or equivalent professional experience, preferably in Clinical Data Management, Health, or Computer Sciences
• Minimum of 2 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry; experience in clinical drug development and working with cross-functional stakeholders.

Nice to Have

• Team leadership experience
• 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
• Understanding of data privacy rules in relation to clinical data exchange

Skills

* Required skills

Benefits