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
- Bachelor's degree in a related health profession or a field related to research compliance
- 5+ years of data management experience in a CRO or sponsor company environment
Professional Work Experience
- Knowledge of CDISC/CDASH standards
- Experience with EDC systems.
- Knowledge of medical terminology and use of coding dictionaries.
- Knowledge of ICH, FDA, and GCP regulations and guidelines related to data management.
- Applicable experience in biotech, pharmaceutical and/or medical device industries preferred.
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Qualifications and Skills
- Strong scientific background and understanding of clinical trials including pharmaceutical, device, operations, and regulatory compliance.
- Proven ability to take independent action to initiate process improvement, when needed.
Other Essentials and Key Success Factors
- Successful track record of working in high-growth and dynamic organizations
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
- Highest levels of professionalism, confidence, personal values and ethical standards
Travel
This position requires no regular travel.
The description and requirements outlined above are general; additional requirements may apply.
