Sr Mgr EDC Development

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profile Job Location:

Warren, OH - USA

profile Monthly Salary: $ 134400 - 219200
Posted on: 16 hours ago
Vacancies: 1 Vacancy

Job Summary

Were growing our Clinical Database Development team and were looking for a thoughtful leader to help us deliver reliable inspectionready EDC solutions that support our key development programs. We provide clear direction consistent processes across studies and caring mentorship so our developers and CRO partners can do their best work. We champion quality standards and regulatory requirements and we celebrate practical elegant builds in Medidata Rave. Well support you as you guide strategy develop talent and shape the standards that move our portfolio forward!

A Typical Day:

  • Oversee CRO EDC database builds and ensure process compliance.
  • Build and configure Rave studies using our Global Library.
  • Program edit checks dynamics derivations and custom functions.
  • Lead UAT setup in Cloud Administration and drive resolution to golive.
  • Configure Coder TSDV and Clinical Views as protocols require.
  • Manage amendments migrations and quick publishes with Rave tools.

This Role May Be For You if you:

  • Balance standards with protocol nuances to craft dependable Rave builds.
  • Guide CRO partners with clarity while maintaining consistent practices.
  • Value compliance21 CFR Part 11 ICHGCP and CDISC are second nature.
  • Move comfortably between strategy oversight and handson configuration.
  • Enjoy coaching developers and contributing to a highquality global library.

To Be Considered
A bachelors degree in mathematics science or a related field is required along with 8 years of EDC development experience in biotechnology pharmaceutical or healthrelated industries and 3 years of peoplemanagement experience. Medidata Rave experience is required and you bring thorough knowledge of Data Management and Clinical Database Development processes and of applicable regulations (21 CFR Part 11 ICHGCP CDISC standards for data collection). Preferred qualifications include Medidata Builder Certification C# programming knowledge and TrialGrid familiarity plus experience with Rave Amendment Manager and Medidata Cloud Administration.

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits which vary by the U.S. benefits may include health and wellness programs (including medical dental vision life and disability insurance) fitness centers 401(k) company match family support benefits equity awards annual bonuses paid time off and paid leaves (e.g. military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US please visit For other countries specific benefits please speak to your recruiter.
Please be advised that at Regeneron we believe we are most successful and work best when we are together. For that reason many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.

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 parental status gender identity gender reassignment military or veteran status or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Companys business.

For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.

Salary Range (annually)

$134400.00 - $219200.00

Required Experience:

Manager

Were growing our Clinical Database Development team and were looking for a thoughtful leader to help us deliver reliable inspectionready EDC solutions that support our key development programs. We provide clear direction consistent processes across studies and caring mentorship so our developers and...
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Discover how Regeneron (NASDAQ: REGN) harmonizes biology and technology to create life-changing medicines. Join our team and explore clinical trials.

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