Clinical Data Management Senior Manager

7 days ago


San Diego, California, United States Proclinical Staffing Full time

Sr. Manager, Clinical Data Management - Contract Opportunity

Proclinical Staffing is seeking a seasoned professional to oversee data management activities in phase 1 - 4 clinical trials. As a Sr. Manager, Clinical Data Management, you will be responsible for ensuring the accurate interpretation and translation of study protocols into validated data collection applications, tools, and systems.

Key Responsibilities:

  • Manage data management activities according to quality standards and regulatory requirements, ensuring adherence to project timelines and budget.
  • Oversee the development of CRFs and CCGs with other functional area representatives, ensuring all data management databases are developed and validated.
  • Manage interactions and deliverables with third-party vendors and CROs, ensuring proper execution of data management activities and providing relevant metrics to the study team.
  • Oversee data review, reconciliation, and cleaning activities for all assigned studies.
  • Ensure high data quality by adhering to corporate, industry, and regulatory standards.
  • Monitor outsourced data management activities for efficiency and regulatory compliance, providing feedback on vendor selection.
  • Cultivate effective working relationships with colleagues, junior staff, vendors, and management, solving problems and escalating issues with proposed solutions as needed.
  • Educate clinical team members on data management processes, workflow, and data standards.
  • Review and provide input on protocols, SOPs, and work instructions for the data management department.
  • Perform ongoing review of study documentation in the trial master file to ensure audit readiness.

About Proclinical Staffing:

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. We are an equal opportunity employer.



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