Description
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role as the Associate Director, Clinical Data Management. This role is accountable for Data Management activities at a program and/or study level that support development and future commercial projects worldwide. This individual will participate as an active member of a multi-disciplinary team to plan and manage the Data Management tasks required for Phase I-IV studies. They will also drive the delivery of study data quality and integrity from study start up through database lock and post-lock archival process.
Roles and Responsibilities
Lead Phase I-IV Sage sponsored clinical study data management activities comprising of internal and external data management resources.
Responsible for the clinical data management activities for a study and/or a program in compliance with regulatory requirements and Sage SOPs under aggressive timelines with high quality and in a professional manner.
Oversee the design, creation, and testing of clinical study databases in accordance with the data collection requirements as defined in the clinical protocol and in alignment with industry best practice guidelines and standards.
Oversee development of data edit check specifications and manual data listings as required.
As Program Lead, ensure consistent program-level data collection, data cleaning, and data management standards for RAVE or other data capture systems.
Oversee and manage Data Management contract service providers or other service providers providing data capture technologies, data management programming capabilities, and data processing capabilities to achieve quality, timely, cost-effective study deliverables.
Ensure all required documents are maintained ensuring preparedness for regulatory inspections.
Review and provide feedback to the clinical team on other study documents, e.g. clinical monitoring plans, statistical analysis plans, and service provider specifications.
Oversee data finalization and database lock activities, including post-lock archival activities.
May drive inspection readiness, quality compliance, and training initiatives pertaining related Data Management for a study or a program.
Serve as the functional representative on project teams, study teams, and development teams including multi-disciplinary interactions.
May participate in the development and optimization of data management SOPs, processes, and initiatives.
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, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Basic Qualifications
BA/BS degree, preferably in the scientific/healthcare field.
10+ years of experience in Data Management in the pharmaceutical/biotechnology industry.
Preferred Qualifications
Experience as lead DM of a Phase II or III clinical study required; ability to be primary DM representative with little oversight required.
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 as well as manage service provider resources and timelines.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and service providers.
Strong team player that has a positive customer service approach and is solution-oriented.
Possesses strong written and verbal communication skills.
Possesses an in-depth understanding of regulatory guidelines, e.g. ICH, GCDMP, 21 CFR Part 11 and their application to Data Management practice.
Knowledge of and experience with MedDRA and WHO Drug data dictionaries.
Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
Proven experience in internal and external inspection activities preferred.
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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