DATA MANAGER II (REMOTE)

About the Role

Key Responsibilities

• Uses understanding of clinical trial concepts and cross-functional protocol requirements to execute assigned study assignments
• Engages with members of the Data Science Solutions (DSS) and cross-functional study teams to effectively execute activities
• Utilizes available technology to execute assigned activities
• Develops and utilizes data standards (e.g., CDASH and SDTM), and protocol requirements in the design and development of key system interfaces and data flow
• Creates study execution documentation including specifications, data management plan, and integrated data review plan
• Executes data management plan and integrated data review plan as required by protocol and team decisions
• Triages issues as they occur and maintains documentation per ALCOA principles
• Performs data review using supplied data review tools and reconciles data from different sources
• Queries clinical sites to clarify data abnormalities
• May lead process improvement efforts within Data and Statistical Sciences
• Mentors junior team members
• Ensures adherence to regulations, GCPs, ICH Guidelines, SOPs, and quality standards
• Stays updated on evolving regulations and policies related to clinical development

Requirements

• Bachelor's degree in business, management information systems, computer science, life sciences, or equivalent
• Master's degree preferred
• At least 4+ years of experience in pharmaceutical, clinical research, data management, healthcare, or related fields
• Strong understanding of clinical trial processes and clinical technology
• Demonstrated success in a fast-paced environment managing multiple priorities
• Leadership traits and ability to coach/lead in a matrix environment
• Strong understanding of GCDMP
• Effective communication, problem-solving, and analytical skills

Nice to Have

• Experience with clinical data standards such as CDASH and SDTM
• Experience leading process improvements in data management
• Knowledge of regulatory requirements and guidelines

Qualifications

• Bachelor's degree (required)
• Master's degree (preferred)
• 4+ years of relevant experience

Benefits & Perks

• Paid holidays
• Health insurance
• Dental insurance
• Vision insurance
• 401(k)
• Paid time off