Responsible for the creation and management of database instances. This includes tasks such as user creation, creating and altering table spaces, configuring listeners and creating and managing rollback segments. Responsible for the daily backup and data export of all database instances including hot backups and cold backups.
Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns including, but not limited to Data collection, Data cleaning, Data delivery, Data reconciliation, Database lock and Data Management activity timelines
Effectively manage, collaborate and communicate with DevOps cross-functional teams and relevant management to report out service delivery status, new operational requirements and service delivery blockers.
Perform any and all functions of the System Analyst I as required to meet corporate commitments and deliverables; in particular, to review or provide standard data specifications and create standard data files through SAS.
Manage and perform internal audits and gap analyses to ensure compliance with ERT SOPs, ICH Good Clinical Practices, and ISO 9001, ISO 13485 and applicable regulatory requirements for all ERT cardiac safety, respiratory, eCOA and technical operations. Develop auditing plans and reports for assigned audits. Maintain the status of identified audit findings in the Quality Assurance Database/CAPA Tracking System.
Defining the Product solution including strategic and tactical road maps, user stories, and delivery plans. Facilitating and supporting cross-functional and external activities required to achieve the planned objectives ensuring that we optimize the demands of both the customer, the business and regulations.
Provide advanced technical support for the eCOA product suite to primarily internal users (Tier 1, Release Engineering, Study Teams, etc). Able to solve complex, high-impact problems requiring expertise in eCOA platform, specialized skills and multi-disciplinary knowledge.
Create the Test Plan and Test Summary and Requirements to Test Script Traceability documents.Collaborate with software and data delivery engineers to understand the changes in new software versions and identify the appropriate set of functional and regression tests needed to verify that new features function as designed and do not cause any undesirable behavior.
Develop and manage corporate quality assurance programs to assure compliance of ERT business processes with respect to applicable regulatory requirements (specifically 21CFR Part 11, Good Clinical Practices and the Computerized Systems used in Clinical Trials Guidance)
Coordinates activities of various cross functional groups, including the Solution Team, Pricing Specialists, Sales Support Associates, and Contracts to move opportunities from Inquiry to Order in and efficient manner.
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, training, and developing employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Manages and drives accountability of a diversified team of Quality professionals responsible for leading individual teams focused on specific Quality initiatives including but not limited to: Internal/Vendor auditing, hosting External audits of ERT, execution of the Designated Complaint Unit (DCU), employee training programs and controlled document management and the GCP Compliance leader.
Develop an intimate knowledge of customer needs and competitive intelligence, identify global market trends and drivers, and formulate and execute strategic product portfolio planning (Build / Buy / Partner strategies)