What are the responsibilities and job description for the Senior Clinical Data Manager (temp) position at Fractyl Health, Inc?
Reports to : Director, Data Management
Position Summary
The Senior Clinical Data Manager at Fractyl Health, Inc. will be responsible for all aspects of the clinical data management activities associated with clinical database design and project oversight, resulting in quality and accuracy of the database for our clinical trial(s).
Primary Responsibilities
- Responsible for coordinating, facilitating, and participating in all data management activities from initiation of protocol, study startup through database lock with minimal oversight.
- Provide Data Management oversight for outsourced projects.
- Provide vendor management.
- Support CRF design, review, and validation of clinical database.
- Author and maintain all project start-up documents; including, but not limited to : eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications
- Perform user acceptance testing for assigned projects.
- Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target with project timelines.
- Prepare data transfer agreements & coordinate the receipt of data transfers.
- Author all database lock documentation for assigned projects.
- Prepare all data cleaning and data status documentation; including, but not limited to : metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc.
- Performed ad-hoc reporting.
- Adverse event and concomitant medication coding using MedDRA and WHO-Drug.
- Responsible for SAE reconciliation.
- Provide data management timelines and cost associated in the project scope of work.
- Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed.
- Ability to support a number of moderate to complex trials with minimal supervision.
- Build successful relationships and seamless interfaces at the project team level and provide timely and effective communication to the study team, trial manager, and Biostatistics.
- Interface closely with Biostatistics and Project Management on the project level.
- Provide mentorship to junior level Data Mangers.
- Perform all activities in compliance with applicable regulations, Fractyl's policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
- Bring a "can do" spirit to work and deliver on other responsibilities as assigned.
Education or Certification Requirements
Professional Work Experience
Qualifications and Skills
Other Essentials and Key Success Factors
Travel
This position requires no regular travel.
The description and requirements outlined above are general; additional requirements may apply.
