Manager Data Management- Clinical Data Standards

The Manager, Data Management- Clinical Data Standards creates and maintains global metadata repository by collaborating with clinical development line function representatives as part of Regeneron Data Governance model. Works with clinical project teams to use defined standards and provides guidance for updates to Regeneron global metadata repository. Partners with other functional areas to establish processes for data collection, analysis and reporting.

A typical day might include the following:

• Develop operational (3rd party and EDC) global clinical data standards following CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology

• Work with external vendors/organizations to develop best practices and advance REGN clinical data standards

• Standardize eCOA vendor/3rd party data collection

• Participate in relevant governance team meetings and provide standards input as assigned

• Act as an authority on SDTM standards to CROs, vendors and internal REGN teams.

• Communicate and collaborate with multiple line functions to implement standards team strategy

• May update functional SOPs, Working Procedures and other internal documents

• Identify and propose process improvements from CDISC/SDTM/CDASH standards perspective

• Provide guidance to study teams on creating eCRFs to support clinical database set up

• Develop and deliver training for REGN standards related processes

• Update metadata definitions and specifications in an MDR system

• May provide data mapping specifications for clinical data acquisition from various external sources including EHR/EMR systems

• Provide support for standardizing and harmonizing external specialty lab data, bioanalytical data, and other central read data.

• BA/BS in health sciences or computer science team. Minimum 5 years working experience in clinical data management, clinical data conversion or clinical data programming. Submission experience is a plus.

• End to end knowledge of drug development process

• Strong experience in implementing Industry Standards (e.g. SDTM CDISC) in either the collection (CDASH) or tabulation (SDTM)

• Project management and strong communication skills

• Familiarization with HL7 interfaces, FHIR capabilities and LOINC standard is preferred

• Strong understanding of FDA/ICH guidelines for clinical study data

• Should be able to work effectively as a member of multi-functional teams across programming, biostatistics, data management and clinical sciences

• EDC build (Rave) experience a plus

• Previous experience with an MDR system is a plus

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.