Sage Therapeutics Manager, Development Systems in EMAIL: Workday@Sagerx.com, Massachusetts
Sage is looking for a Manager of Clinical development systems, R&D Technology team to lead the partnerships with key business leaderships in R&D business functions as well as manage key critical capabilities in support of Sage’s Digital and Transformation initiative. The Manager of Clinical Development Systems will serve as an expert technical leader, Systems SME, collaborating with R&D functional leads in performing business analysis, business case development, architecture review, selection, implementation, configuration, and maintenance of critical technologies.
Roles and Responsibilities:
Partner with stakeholders throughout full lifecycle of data sciences, regulatory and safety systems integration – from defining business need, project planning, requirements management, vendor selection, development, deployment, and end user adoption – and provide ongoing management and functional oversight for all electronic development systems.
Partner with external service providers.
Serve as the system administrator (owner) of the Data sciences, Regulatory and PV teams.
Analyze business processes, propose solutions for current and future needs, and assist in implementing recommended improvements, in accordance with Sage operating standards.
Assure system is properly implemented according to business requirements and FDA Part 11 requirements. Ensure systems maintain GxP validated state, including preparation of documentation, execution of testing, management of user access, and coordinating change management and related processes.
Develop and manage system documentation including, but not limited to, user requirement specifications, configuration specifications, user acceptance testing plans, SOPs, and validation records.
Collaborate with users to establish operational workflows and transform the workflows into system configuration.
Work with functional leaders to align on key measures and metrics for success.
Oversee the creation and customization of program- and department-level analytical reports and dashboards to support a data-driven operating model.
Lead ad-hoc analytical projects.
Develop and maintain internal data repositories, as needed.
Drive innovation and the delivery of continuous process improvement.
Experience, Education and Specialized Knowledge and Skills:
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. 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.
Bachelor’s degree required (scientific or technical discipline)
5+ years of experience working in the clinical environment managing clinical development systems (for example, clinical data analytics, Veeva platforms, RIM technologies, PV/safety systems such as Argus, data science platforms such as SAS ), underlying processes, and data.
At least 7 years of experience in pharmaceutical/biotechnology and extensive knowledge of ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority regulations as they pertain to the operational aspects of clinical studies
Post-graduate degree preferred.
Experience with Veeva Vault and Veeva Vault configuration. Veeva Certified Administrator a plus
Proactive and positive management approach.
Exceptional listening and problem-solving skills
Experience in developing business specifications/requirements and user acceptance testing for computer systems.
Experience with vendor management and oversight of data exchange, migration and integration.
Demonstrated ability to analyze complex issues, to develop relevant and realistic recommendations and plans, and to drive projects to consistently meet deadlines.
Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects, both working independently and within a team.
Flexibility to adapt to the dynamic needs of a growing biotech company and to manage change effectively.
Ability to learn quickly and adjust approach to problems based on feedback.
Demonstrated experience working in a matrix environment.
Strong team player that has a customer service approach and is solution oriented.
PC literacy required, including fluid use of common MS applications.
Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
Excitement about the vision and mission of SAGE.
Number of Openings:
#Biotechnology #Careers #ThisIsSage
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 (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEO is the Law - Poster Supplement
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.
Protected personal characteristics include: age, race, ancestry, color, sex, national origin, sexual orientation, gender identity or expression, religious creed, mental or physical disability, pregnancy, genetic information, marital or civil union status, participation in the uniformed services of the United States, or any other characteristic protected under applicable federal, state or local law. To learn more, see Sage's Anti-Harassment and Equal Opportunity Policy
- Sage Therapeutics Jobs