Employment Clinical Data Specialist
Company Overview
Auxogyn, Inc. is a privately held medical technology company focused on advancing women’s reproductive health by applying its novel scientific and clinical knowledge of early human developmental biology to the field of assisted reproduction and in vitro fertilization (IVF) procedures. Auxogyn’s first product in development combines a proprietary computational algorithm with developmental biology imaging capabilities to assess early embryo viability at the four-cell stage of development by identifying embryos that have the possibility of developing into a blastocyst. The company is funded by the leading life science venture firms Kleiner Perkins Caufield & Byers, TPG Biotechnology and Merck Serono Ventures.
Position Summary
As a member of Auxogyn Clinical Research Team, this position is responsible for management of data and assuring quality of data delivery. This position is the key liaison with internal and external business partners responsible for the development of data management systems and data cleaning activities. This position will have a moderate amount of interaction with clinical study leadership, data management support teams, and statisticians.
Additional responsibilities include definition of data management related business requirements ensuring quality of data, and supporting and/or working with project teams, disciplines or functions. Provides ongoing support and subject matter expertise for data management related activities.
Major Duties and Responsibilities
- Initiate, plan, execute and manage all aspects of data management from case report form development to the final database lock. This includes case report form design and development, database/edit check specification requirements definition, user acceptance testing, creation and maintenance of the data management plan and the data quality plan.
- Ensure the successful execution of data management elements of project plan. This includes monitoring tasks and managing timelines related to data management deliverables, database development and database lock/freeze/snapshot.
- Plan, execute and manage multiple projects of moderate complexity; utilizing project management tools and techniques.
- Maintain and provide project timelines and effectively communicate project status report.
- Complete Data Entry for all studies.
- Provide communication of risk & mitigation actions for all data management related deliverables.
- Define data review requirements and processes to ensure delivery of the highest quality of data (study unique needs, end point analysis, higher level review, escalation of issues).
- Follow and implement data management standards, best practices and assure Standard Operating Procedures compliance.
- Communicate with company leadership regarding the status of specific projects.
- Facilitate small group discussion on moderately complex data management topics.
Preferred Qualifications
- Data management experience in medical device and/or pharmaceutical industry
- Experience analyzing clinical protocol requirements and translating them into data management requirements
- Experience with case report form design
- Experience working in clinical data management applications (e.g. Oracle Clinical, Clindex) and report tools
- Experience working with technology partners (database developers, testers)
- Experience working with EDC
- Project Management experience
- Experience with project management tools, spreadsheets, word processing, database applications (e.g. Microsoft Project, Excel, MS Word)
- Experience writing SOP’s and DMP’s
Education and/or Job Experience
- Bachelor’s degree
- 5+ years clinical research experience
Special Skills, Abilities, and Requirements:
- Knowledge of good data management and good documentation practices, Food and Drug Administration 21 CFR Part 11 regulation, and Health Insurance Portability and Accountability Act.
We offer a competitive compensation package including health insurance, stock options and a challenging work environment. We are an equal opportunity employer.
Qualified candidates please send your resume to [email protected].
