Associate Director, Clinical Operations Business Solutions Partner

The Associate Director is the Product Owner for our Clinical Trials Management System and the Operational Data Repository (ODR). They are the Solution Partner for Global Clinical Operations (GCO). We are looking for a leader to drive strategies and capabilities for our CTMS and translate these strategies into new solutions, technologies and services. You will have significant interaction and cross domain responsibilities with Data Management, Regulatory, Safety and Medical Affairs.

As the Clinical Operations Business Solutions Partner a typical day might include the following:

• Partnering with functional area leaders to define the vision, strategy, and scope of business processes supported in the CTMS
• Helping to align process definitions and product functionality across all impacted groups
• Translating business needs into delivery of technology capabilities, data integrations, and services
• Working with Business Operations, and the broader GDS team, to handle operational data integration
• Aligning solutions with business goals and objectives to ensure outcomes are realized and ensuring value propositions are effectively collected, communicated and measured post-delivery
• Preparing and managing budgets and resources in collaboration with GDS Leadership, the Program Management Office and Finance
• Oversight of the Software Development Life Cycle including ensuring the business outcome is understood, the documentation of requirements, planning for Go live support and business readiness and successfully handing off implemented system for on-going support
• Partnering with vendors in keeping abreast of technology trends and applicability to business needs
• Introducing new innovative solutions and technologies to functional area
• Participating in industry groups and forums

This role may be for you if you have:

• A deep knowledge of processes and systems used for Clinical Trial Operations
• Experience managing technology capability identification, selection and implementation in Clinical Trial Operations
• The ability to identify the cross-functional process requirements for those served by a CTMS and to drive alignment
• Established the strategy for delivering solutions and related service capabilities
• Expertise in GCO processes, plans, objectives, drivers, and issues
• Managed external policies and regulations to ensure effective service delivery

To be considered for this opportunity you must have:

A BS/BA Degree with ten plus years or MS/MA/MBA degree and eight plus years relevant experience. Direct, hands-on experience implementing or operating a CTMS and/or a Clinical ODR. System experience leading delivery of a complex cross-functional system in Clinical Operations area. Experience with data integrations required to provide operational reporting to support clinical trial execution. Solid understanding of SDLC methodologies, CFR Part 11 compliance, data aggregation tools and capabilities. Good problem solving, technical writing and verbal communication skills. Strong track record of project management, partner management, budget management and collaboration skills. Willingness to travel up to 25%.

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.

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