Associate Director, Clinical Systems Business Partner

Location
Tarrytown, New York, US
Posted
Jul 13, 2018
Ref
13409BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

Position necessary to deliver key strategic initiatives in Business Operations and Clinical Trial Management including Operational Data Repository (ODR) and Clinical Trials Management Systems (CTMS). The key priorities are successful implementations, operations and on-going evolution of the ODR and CTMS. Will provide ownership of processes supported in the CTMS.

Duties:

• Accountable for understanding the business needs, priorities and challenges of Clinical Trial Management (CTM) and Business Operations to establish the strategy for delivering systems and related service capabilities.

• Accountable for defining the business processes supported in the Clinical Trial Management System (CTMS) by driving alignment across all impacted functional areas

• Provide process ownership for the CTMS by defining the scope of business processes supported in the CTMS, and driving process definitions across all impacted stakeholders

• Provide strategy and accountability for the implementation and operations of the ODR and underlying integrations with CROs, labs, other vendors and internal systems.

• Serve as the Systems Business Partner by translating business needs into delivery of technology capabilities and data integrations.

• Partner with Business Operations to define the strategy for operational data integration. Partner with System Operations group to drive towards high quality data integration integrations

• Ensure that technology capabilities are effectively identified, implemented and utilized in GCP and non-GCP environments.

• Provides and supports tools and reports for the management of information.

Supervisory Responsibilities:

• None

Requirements:

BS/BA Degree with 10+ years relevant experience. MS/MA/MBA degree and 8+ years relevant experience.

• Knowledge of business processes and systems used for Clinical Trial Operations

• Direct, hands-on experience implementing or operating a CTMS and/or a Clinical Trial Operational Data Repository

• Ability to identify the cross-funcational process requirements for stakeholders served by a CTMS and driving definitions and alignment

• System experience managing delivery of a complex cross-functional system in Clinical Trial Operations area and managing on-going enhancements

• Experience with data integrations required to provide operational reporting to support clinical trial execution

• Strong knowledge of SDLC methodologies and CFR Part 11 compliance

• Strong knowledge of data aggregation tools and capabilities

• Experience managing IT capability identification, selection and implementation in Clinical Trial Operations

• Good problem solving, technical writing and verbal communication skills

• Ability to effectively manage multiple priorities with a sense of urgency

• Attention to detail and accuracy of work

• Strong track record of project management, stakeholder management, budget management and collaboration skills

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.