Manager Clinical Data Management

Senior Manager, Global Clinical Affairs Data

Location: Remote

Pay: Up to $100 an hour

Job Type: Long Term Contract

The Senior Manager, Global Clinical Affairs Data oversees end-to-end data management for all global clinical studies. This role is responsible for identifying data sources, managing data collection and processing, ensuring data privacy and integrity, defining data flows, and coordinating the distribution of data. The Senior Manager also summarizes data analyses and partners in the preparation of formal regulatory reports.

Responsibilities

• Identify and manage data sources; establish efficient data collection pathways; oversee data processing, data flows, data privacy, data integrity, and data distribution for all global studies.
• Implement quality control checks to ensure accuracy, troubleshoot data issues, and maintain high data integrity.
• Conduct User Acceptance Testing (UAT) for clinical databases.
• Collaborate with biostatisticians to ensure alignment on data collection and analysis strategies.
• Support study close-out activities and manage database lock procedures.
• Ensure adverse event documentation is complete and sufficiently detailed for adjudication.
• Work cross-functionally to collect all study data related to adverse events.
• Manage communication of adverse event reports to the Medical Monitor or Data Safety Monitoring Board, as applicable.
• Coordinate with Medical Affairs to finalize the report shell for regulatory submissions.
• Summarize data analyses and collaborate in the development of formal reports for regulatory agencies.
• Manage post-study data distribution to clinical sites.
• Oversee data retention practices to ensure compliance with internal processes and regulatory requirements.
• Define, maintain, and improve internal data management processes for global studies.
• Develop data management plans for all global studies.
• Perform other duties as assigned.

Education & Experience

• Bachelor’s degree or an equivalent combination of education and experience.
• Minimum of 10 years of relevant experience.
• Strong analytical skills, attention to detail, and interpersonal communication abilities.
• Knowledge of applicable regulatory guidelines and requirements.

Skills & Competencies

• Excellent written and verbal communication skills.
• Ability to collaborate effectively across multiple functions and levels of the organization.
• Proficiency with word processing, spreadsheets, databases, and internet research tools.
• Flexible, adaptable, and comfortable working in a fast-paced environment.
• Strong organizational skills with the ability to prioritize effectively.
• Demonstrated ability to generate and maintain accurate, complete records.