Senior Manager, CDM - EDC Programming job in New Brunswick, USA

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Job type: Permanent

Discipline: Project/Study Manager (CSM/CPM), Program Manager / Director, Clinical Scientist

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Senior Manager, CDM - EDC Programming for a top biotech company located in New Jersey. This position will be a member for the Clinical Data Management (CDM), Standards and Systems group and responsible for the programming and maintenance of the Global Standards Library.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

Develop standards within Medidata Rave Global Library in accordance with standardized database structures and/or study specific eCRF specification
Database testing to ensure optimal and in accordance with the eCRF specification and programmed edit checks
Develop and test data entry screens according to the eCRF specification and to facilitate data entry and data management
Develop and test derivations, dynamics, matrices, and dynamic search lists in accordance with the eCRF specification
Develop and test edits checks according to the standard Data Validation Plan
Design and Test C# programming involving complex visit schedules, derivations, alerts and setting subject status
Work closely with Standards cross-functional team, Data Managers, other programmers to develop or interpret the eCRF specifications, DVP specifications or other programming specifications for listing and other reporting needs
Work with Medidata, as needed, to implement/integrate Rave with other Medidata modules
Perform complex database Migrations
Follow Data Management and Database Programming standard operating procedures, Medidata best practices and applicable FDA Guidance

Skills and Requirements:

Bachelor's degree required in computing field of study and/or equivalent (e.g., number of years of experience and/or skills)
8 years of direct experience in Medidata RAVE or similar
Knowledge/technical requirements in C# (e.g., excellent knowledge and understanding of CDASH, CDISC, and SDTM)

If you are having difficulty in applying or if you have any questions, please contact Maggie Sewall at (+1) 619-822-2469 or m.sewall@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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