Clinical Data Manager II

What can we offer you?

Apart from job satisfaction, we can offer you:

HEALTH

• Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA)

YOURSELF

• Paid time off policy including holidays and sick time
• Internal growth and development programs & trainings

WEALTH

• 401(k) program, life & accident insurance and disability insurance

The Clinical Data Manager II is an end-to-end data custodian and plays a key role in managing data and ensuring its accuracy, completeness, and compliance with regulatory standards while providing data management support to study teams. This role requires Therapeutic Area Subject Matter Expertise and in-depth process knowledge and critical thinking. The Clinical Data Manager excels in defining overall data standards, data collection requirements, data import, extraction, reporting, and analysis methods. The incumbent shall demonstrate a strong working knowledge of Good Clinical Data Management Practices.

Job Purpose

The Clinical Data Manager II is an end-to-end data custodian and plays a key role in managing data and ensuring its accuracy, completeness, and compliance with regulatory standards while providing data management support to study teams. The Clinical Data Manager excels in defining overall data standards, data collection requirements, data import, extraction, reporting, and analysis methods. The incumbent shall demonstrate a strong working knowledge of Good Clinical Data Management Practices.

Key Responsibilities

The Clinical Data Manager II plays an essential role in the efficient design of project databases, the integration of data from multiple sources, and the reporting and analysis of key study data metrics. The incumbent will recommend and drive solutions for database design and data reporting and has demonstrated foundational knowledge and judgement to problem solve and recommend innovative solutions for quality and efficiency gains. Has a competent understanding of process with minimal supervisory oversight needed. This role is critical for meeting sponsor study data endpoints and requirements.

• Oversight of multiple concurrent projects
• Act as sponsor portfolio lead representative
• Provide guidance as clinical database development subject matter expert
• Design study CRFs and databases utilizing eCRF library

• Create study Data Management Plan and deployment roadmap
• Monitor study timelines and communicate risk

• Develop database edits, rules, and derivations

• Prepare tracking reports and metrics

• Facilitate study team involvement in database development

• Prepare data extracts and processing for sponsor deliverables

• Communicate with sponsors regarding study data processes, endpoints, and overall data management process

Functional Competencies (Technical knowledge/Skills)

• Technical project management and oversight

• Task creation and tracking via ticketing software
• Proficient with clinical data management systems

• Experience working with research support or clinical team

Experience, Education, and Certifications

• Bachelor's Degree in Life Science (Biology, Medical Technology, Research Psychology, Math or Health Science or equivalent experience in a related field
• 3-6 years practical work experience in a clinical or technical setting
• Demonstrated experience in team settings to achieve goals
• Demonstrated experience with clinical data management systems
• Experience working with research support or clinical team

• English: Fluent

• Participate in eCRF library additions and updates