Senior Manager, Clinical Data Management Lead

4 weeks ago

San Diego, California, United States ANAPTYSBIO Full time
Job Summary

The Senior Manager, Clinical Data Management will be responsible for overseeing data management activities in phase 1-4 clinical trials. This includes ensuring the interpretation and translation of study protocols into validated data collection applications, tools, and systems, as well as the cleaning and validation of data for delivery to analysts.

Key Responsibilities
  • Manage data management projects to ensure quality standards, regulatory requirements, and project timelines are met.
  • Oversee the development of CRFs and CCGs with other functional area representatives and ensure all applicable data management databases are developed, validated, and meet AnaptysBio's requirements.
  • Interact with 3rd party vendors and CROs on collection, transfer, reconciliation of study specific data, and ensure proper execution of data management activities.
  • Responsible for the oversight of data review, reconciliation, and data cleaning activities for all assigned studies.
  • Accountable for hands-on management of trials and resources while maintaining a high level of data quality.
Requirements
  • Bachelor's degree or equivalent combination of education and work experience, 6+ years of relevant CDM experience in biotech and/or pharmaceutical/drug development.
  • Vendor management and global experience is highly preferred.
  • Experience working effectively in a smaller company environment with experience in a hands-on early development role is a plus.
  • Demonstrated ability to handle a high volume of highly complex tasks within a given timeline.
Personal Competencies
  • Effective communication and interpersonal skills.
  • Ability to work effectively in a team player environment, intensely committed to success and getting the job done well.
  • Self-motivated, independent, and results-oriented.
  • Excellent organizational and problem-solving skills with the capacity to organize assignments and work within deadlines.
Work Environment

The work environment is typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. May be required to travel by plane or car.

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