Open Positions

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.

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What will I do?

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• 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

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Minimum Education and Qualifications

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• 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

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Travel

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• Expected travel: 10%