Sr. Clinical Data Manager (Sr. CDM)

The Sr. Clinical Data Manager (Sr. CDM) will have end to end experience in clinical data management.  Play a key role in the development, maintenance, close-out of clinical trial database to ensure the generation of high-quality data.

What will I do?

  • Provides DM leadership across assigned trial(s)and acts as the clinical data manager where needed.

  • Provides feedbacks to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards

  • Performs DM activities for start-up of a study including preparing the eCRF, CRF completion guidelines, Data Monitoring plan, UAT procedure and performing UAT for all assigned databases

  • Performs DM hands on activities during the course of the study. Disseminates study level information to the clinical study team and ad hoc meetings

  • Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation.

  • Supports and assists junior staff for assigned trials

  • Provides effective input in DM initiatives and innovations for quality, efficiency, and continuous improvement in scientific and operational excellence.

  • Tracks and reports status and progress for assigned trials; generating unique study specific reports for trend analysis and to assist with site management

  • Ensures adherence to GCP, DM standards, SOPs, work instructions and process guidelines

  • Manage assigned DM timelines and priorities

  • Perform data quality review for quality issues and general data trends

Minimum Education and Qualifications

  • Bachelor’s degree in life sciences, health, or other relevant field of study required

  • Minimum 5 years of data management experience

  • Strong working knowledge of (e)CRF design and data management functions/activities

  • Advanced knowledge of Microsoft office

  • Proven track record of strong project management skills and experience managing data management activities

  • Highly organized with strong attention to detail, clarity, accuracy, and conciseness

  • Experienced with all aspects of DM including Database build, Study Start-up, Study Conduct, and Database Closure activities

  • Must have excellent written and verbal communication skills

  • Strong collaboration skills regarding internal and external teams, and working in a cross-functional team environment

  • Ability to laugh at yourself

Travel

  • Expected travel: 10%

Think that you are the right candidate? GREAT!

Axial Therapeutics™ is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Note to Employment Agencies

Axial Therapeutics™ values our relationships with our Recruitment Partners and will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Axial Therapeutics™ is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Axial Therapeutics™ who is not a member of the Human Resources team.