Description
General Scope and Summary
Sage Therapeutics is searching for a creative resource for the role of Associate Director within Clinical Data Standards. This role is accountable for the development, maintenance, and socializing of the Sage's clinical data standards. This role will report to the Head of Clinical Data Standards (CDS).
The Clinical Data Standards team, in collaboration with partners, establishes and drives the strategy of Sage's global data standards, processes, and technologies across the clinical data continuum for quality of deliverables and global data interoperability. This individual will provide Data Standards leadership and expertise to Sage Data Science and Clinical Operations staff. This role is responsible for Standards Governance to ensure proper utilization of standards, adherence to standards processes, and the timely, thorough assessment of library enhancements and deviations. This individual builds relationships across the global Sage organization and with Data Science Clinical Service Providers (CSP) in support of the standards implementation.
Roles and Responsibilities
Develop Sage's Global Data Collection Standards (CRF, non-CRF, and operational) under the direction of the Head of Clinical Data Standards.
Develop and maintain SDTM mappings (from collection) and update terminologies.
Partner with Clinical Data Management for activities related to study design and setup in compliance with regulatory requirements and Sage SOPs.
Collaborate with functional representatives and external vendors to develop and maintain standards.
Triage user requests for new standards, changes to existing standards, or deviations and provide inputs for key discussions and decisions.
Facilitate and participate in governance council meetings, organizing content and presenting to the council.
Draft communications, such as newsletters, for socializing updates in standards.
Engage with study teams as the Standards SME, socializing and educating standards and Standards' processes.
Conduct periodic review and development of metrics to support the CDS organization.
Work with standards management technologies such as Metadata Repositories, P21 conformance tools, and custom tools.
Provide input for development of SOP Work Instructions and job aids.
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, the ability to develop important relationships with key stakeholders, and the ability to analyze complex issues and provide recommendations. Must be enterprise minded and have a standards mindset. Must have demonstrated experience working in cross-functional teams and the ability to be focused on the science being supported.
Basic Qualifications
BA/BS in the scientific/healthcare field.
7+ years of experience in Clinical Data Standards with 3+ years of experience in Data Management, Statistical Programming, or Biostatistics in the pharmaceutical/biotechnology industry.
Preferred Qualifications
MS and experience in CNS/Neurology preferred.
Excellent understanding of the concept of data chain and traceability.
Proven track record for development and management of a standards library.
Extensive knowledge of CDISC (CDASH, SDTM, and CT).
Knowledge of RAVE EDC, medical and statistical terminology, MedDRA, and WHO Drug data dictionaries is must. Hands-on experience is a plus.
Excellent experience working in cross-functional team-oriented environments.
Experienced working with metadata repositories and basic knowledge of ADaM and submission packages is highly desirable.
Possesses an in-depth understanding of regulatory guidelines e.g., ICH, GCDMP, 21 CFR Part 11 and their application to data standards.
Understanding of ICH and regulatory environment as it pertains to data.
Understands the scope and focus of clinical studies in phases I-IV and has a proven ability to perform the tasks and manage service provider resources and timelines.
Attention to detail and the ability to work individually, within a multi-disciplinary team, with all levels of management, as well as with external partners and service providers.
Strong team player that has a positive customer service approach and is solution-oriented.
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.
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.
Equal Opportunity Employer. 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.
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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.
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