Associate Director, Development Systems

Sage Therapeutics, Inc.
Cambridge, Massachusetts 02142
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  • Job Type
    Employee
  • Job Status
    Full Time

Associate Director, Development Systems (Sage Therapeutics, Inc.; Cambridge, Massachusetts): Under minimal direction, this individual will plan, implement, and maintain the operation and performance of all administrative and management tasks necessary to maintain application operation, install new systems, develop reports and ancillary software, and maintain system security and data integrity. The individual will use their knowledge of the sciences to interface with system users and vendor contacts, and will assist in application selection and business process development. Specific job duties include: monitors and controls the performance and status of systems used in pharmaceutical development, including clinical data management and analysis systems, clinical trial management systems, pharmacovigilance, and others; utilizes software development, extraction, and analysis tools to aid users in data capture, data management, data reporting, and data analysis, while maintaining data security and integrity; supervises operation and use of off-the-shelf development applications, basic server database engines, and ancillary systems to maintain maximum application performance; develops and supports data integrations and data flows between R&D systems; provides supervision and direction to internal compliance personnel and software quality personnel; identifies resource requirements and staff allocations to support validation activities; acts as liaison to scientific community for system selection, implementation, and operation, and to outside vendors during installation, modification, training, and support of application software; monitors software requirements, determines application utilization, and recommends upgrades/enhancements as needed; monitors application security and collaboration access; monitors and responds to application problems using appropriate problem determination tools; tracks problem occurrence and resolution; identifies, diagnoses, and repairs complex problems; provides project leadership in planning, design, implementation, and support of research applications; insures interface with existing application, network, and operational server environments; assures that GxP and other regulatory requirements are successfully established and met during system implementations and assures adherence to all regulatory requirements during system operation and change management activities; develops and implements operational standards and procedures for development applications, including those for performance, backup, compliance, and security; interfaces with operations staff for development and monitoring of off-hours and special procedures; coordinates the storage and management of data generated by CRO's and other partners as part of a virtual development model; provides application implementation guidance to desktop support specialists, network engineers, and server administrators; provides training, troubleshooting, and software development assistance to users; and provides direction and assistance to science users in extracting and analyzing data. Occasional (up to 15%) domestic travel may be required.

Apply online at https://careers.sagerx.com. Ref: R000307. An EOE.

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Requirements

Minimum requirements: Bachelor’s degree in Computer Science, Information Technology, or a related field plus 7 years of experience in a commercial drug development IT support environment. Must have: 7 years of experience with pharmaceutical development applications, such as Clinical Trial Management Systems, or Pharmacovigilance Systems; 7 years of experience with life science analytical applications, support techniques, science data reporting, and formatting tools; 7 years of experience in project management related to the selection, installation, and management of application software systems used in the development process; 7 years of experience with operating Windows-based PCs and working with networked and cloud-based application environments, including web platforms; and proven ability to work well with staff members in all levels of the company and in all business areas, and with the user community.(Unless otherwise specified, Sage Therapeutics is not seeking a specific amount of experience. All experience can be gained concurrently).

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Associate Director, Development Systems

Sage Therapeutics, Inc.
Cambridge, Massachusetts 02142

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