The Clinical System Owner is a key member of the Global Development Solutions (GDS) organization, responsible for managing GD Systems Operations for existing systems and providing support to project teams for new system(s) implementation. This individual collaborates with partners on the day-to-day support of systems including direct supervision of MSPs, while also focusing on improving operational support.
The Clinical SO will provide operational direction and oversight of projects, work packages, and change control processes, within the Global Clinical Operations solutions portfolio. The SO is supported by the Technical System Manager (TSM), Operational PM/BA, vendors and Managed Services Providers.
This leader will also provide system support for projects and a portfolio of applications enabling the Regeneron GCO including teams. The systems that will be supported include the following:
⦁ Veeva Vault Clinical
⦁ Operational Data Repository (ODR) - SaaMa - Analytics Platform
⦁ Online video platform - Panopto
⦁ Study Optimizer - IQVIA
⦁ Site Level Optimization (DQS) - IQVIA
⦁ Resource Management - Intrinsic
⦁ Additional systems to be deployed (Site Portal, Investigator Alert Letter Distribution, etc.)
In this role, a typical day might include:
⦁ Overseeing data mapping and handling of QC of data between source and target systems:
- 1. Handling QC of data between source and target systems after ETL process.
- 2. Supervising vendor work to problem-solve and successfully load data.
- 3. Reviewing the work with various partners to understand business impact of the data.
⦁ Implementing solutions involving ODR, Regeneron's Data Lake, NiFi and/or an external vendor's environment.
⦁ Collaborating with IT Data Platform Systems Group, Global Development Systems Group, etc.
⦁ Developing Data Quality Frameworks to fix problems at the source
⦁ Handling assessment of sophisticated data integration situations with clearly explaining the issues and providing suggestions for path forward
⦁ Ensuring day-to-day operational support meets business expectations and compliance requirements for the user base of Clinical Operations Systems.
⦁ Partnering with the Business Process Owner and GCO Business Solutions Partner(s) to implement new systems in the GCO portfolio.
⦁ Running system operating committee meetings, operational working groups, system change requests, release management for upgrades to existing clinical systems.
⦁ Providing direction and expertise on projects to effectively manage business user expectations, timelines, and budget.
⦁ Maintaining the validated state of GxP systems within the Clinical Systems portfolio.
⦁ Working collaboratively with Corporate IT in the management of enterprise systems, the development and adherence to standards and governance, enterprise architecture and common infrastructure
⦁ Acting as point of contact for GDS solutions in support of GDS Team members as well as the functional business units within GD.
⦁ Ability to travel up to 25%
This role might be for you if:
You have shown success managing complex high-impact IT projects from start to finish
You are comfortable working in an ambiguous environment leading multiple, frequently changing priorities.
You understand the Global Development R&D business domain and/or technology very well, and can analyze business challenges and present technology solutions.
You have strong proficiency in Veeva, Adobe, Office and/or off-the-shelf software products that support Clinical Operations business.
You are experienced in supporting and administrating Clinical Operations systems
You're well-versed in drug development cycle and clinical and regulatory business processes
You have solid knowledge of business analysis, system design and producing quality documentation
To be considered, you must have a Bachelor's degree and at least 10 years of experience directly managing IT contractors and staff. You'll also need solid understanding of SDLC methodologies and CFR Part 11 compliance. We're also seeking a leader knowledgeable in ETL issues, data mining and database structures who is able to coordinate resolution of data issues from error log files. Previous consulting experience is required as well.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.