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Global Librarian, Clinical Data Standards Consultant

  • Consultants
  • US - Remote
  • Worker Status: Contingent Worker
  • Time Type: Full time

Description

General Scope and Summary

Sage Therapeutics is searching for a creative and resourceful thinker for an important role of Global Librarian, Clinical Data Standards. This role is accountable for the development and maintenance of Sage’s global clinical data standards. This role will report to the Head of Clinical Data Sciences. The Global Librarian is responsible for building clinical data standards global library in RAVE EDC for SAGE. In this role, you will work collaboratively with the Clinical Data Standards team, Data Managers, and multiple other functional groups to complete tasks of creating data standards library and components, and reviewing tasks for clinical trial databases.

Roles and Responsibilities

  • Develop SAGE’s clinical standards global library.

  • Develop, program, test, and maintain global library eCRFs, external data specifications, edit checks, folders, matrices, and custom functions in Medidata Rave's Architect using Sage standards.

  • Interpret requirements from the Standards team and other stakeholders.

  • Participate in governance meetings and provide input.

  • Collaborate on the development of CRFs to support database build and standardization efforts.

  • Routinely interface with cross-functional team members.

  • Collect, analyze, and document database requirements and provide consulting and training to the team on feature availability, design challenges, and potential risks.

  • Manage global code lists and dictionaries.

  • Identify and implement checks and other database tools to report study conformance to global library.

  • Provide input to clinical trial protocols for database configuration requirements.

  • Provide technical input on data management plans and other CDM documentation.

  • Collaborate on the validation of the clinical trial database and related components.

  • Manage system user activation and removal requests.

  • Support CAPAs as needed.

  • Serve as the subject matter expert for one or more Standards Operating Procedures.

  • Participate in system upgrades to ensure adequate testing of new and/or modified features.

  • Manage development deliverables to meet overall timelines and objectives.

  • Contribute to the creation and validation of reporting tools, standard applications, and enhanced processes.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.  Must have excellent interpersonal skills and the ability to develop important relationships with key stakeholders.

Basic Qualifications

  • BA/BS degree in STEM field, or equivalent combination of education and related experience.

  • 7+ years of professional experience in clinical database development.

Preferred Qualifications

  • Must have CDASH and SDTM knowledge and advanced knowledge of clinical database design in Medidata Rave.

  • Experienced in RAVE EDC and RAVE Classic, as well as writing edit checks and custom functions.

  • Demonstrated application of Good Clinical Practices (GCP), data management best practices, and regulatory requirements in the execution of clinical trial operations.

  • Experience in CNS/Neurology is preferred and experience with orphan indications will be favorably considered.

  • Understands the scope and focus of clinical studies in phases I-IV and has a proven ability to perform the tasks.

  • Possesses an in-depth understanding of regulatory guidelines, e.g. ICH, GCDMP, 21 CFR Part 11 and their application to data standards.

  • Strong team player that has a positive customer service approach and is solution-oriented.

  • Knowledge of and experience with MedDRA and WHO Drug data dictionaries.

  • Experience working with all levels of management and consulting with key business stakeholders, working in cross functional teams, and taking directions from data standards.

  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and service providers.

  • Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

  • Excitement about the vision and mission of Sage.

Job ID: R001541

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All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

EEO IS THE LAW

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We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.

Employment applications

Employment applications are processed through a website that is not owned or controlled by Sage Therapeutics, Inc. Sage Therapeutics, Inc. makes no representation as to the accuracy of the information contained on websites it does not own or control. Sage Therapeutics, Inc. does not recommend and does not endorse the content of any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

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