Lead Mapping Programmer
Jobbeschreibung
Schweiz
Merck Sharp & Dohme (MSD)
03.05.2024
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Job DescriptionPrimary activities include, but are not limited
to:Assumes the responsibilities for all data mapping deliverables
including SDTM structure set-up and transformation maps to support
multiple clinical programs. Coordinates and participates in the
following activities:30% Design, build, maintain, test, and document
data mapping specifications based on clinical database structures
establish by Global Clinical Data Management and Clinical Research.
Mapping specifications must meet SDTM structure requirements utilizing
DMW and E2E visibility tools to ensure quality and timeliness of data
flow to the Clinical Data Repository. Review the technical
feasibility needs for transformations and technically implements them
in support of the Business Rules required for SDTM compliance and the
Clinical Data Repository in support of Analysis and Reporting
performed by Scientific Programming of study team proposed reports.
Work effectively among RaM Mapping team to communicate issues and
ideas to improve the business.30% Support the standard library
development for data mapping to the clinical data repository including
support of the business rules utilized for Analysis and Reporting and
transformations to verify data transfer between and across the various
databases among data collection, reporting, and the data
repository.15% Under proper change management, responsible for change
requests and incidence correction into clinical database. Ongoing
support in a dynamic and matrix organization. 25% Participate in
extra activities including, but not limited to, study improvement task
forces, automations, initiatives, testing of new systems, and ongoing
training and mentoring.RequirementsEducation:At least B.A. or B.S.
degree, preferably in mathematics, science, a health care related
discipline, or computer science.Knowledge and Skills:5+ years’
experience withCDISC Standards, (SDTM, CDASH,
Define.xml)SAS/R/Python/PLSQLSolid knowledge of Clinical Database
Development/Reporting toolsSolid knowledge of System Development
Lifecycle Management / system validation knowledge Solid knowledge of
drug discovery process, FDA regulations, GxP guidelines, ICH
guidelines, clinical database cleaning process, and 21 CFR Part 11.
Solid knowledge of database structures and available tools to manage,
extract, report and warehouse data. Strong communication skills (oral
and written) with the ability to communicate with both the technical
and business areas. Strong organizational and problem-solving skills.
Ability to work cross functionally and as part of a team.Able to work
independently, under pressure and change environment with
flexibility.Current Employees apply HERECurrent Contingent Workers
apply HERESearch Firm Representatives Please Read Carefully Merck &
Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC,
Rahway, NJ, USA, does not accept unsolicited assistance from search
firms for employment opportunities. All CVs / resumes submitted by
search firms to any employee at our company without a valid written
search agreement in place for this position will be deemed the sole
property of our company. No fee will be paid in the event a candidate
is hired by our company as a result of an agency referral where no
pre-existing agreement is in place. Where agency agreements are in
place, introductions are position specific. Please, no phone calls or
emails. Employee Status: RegularRelocation:No relocationVISA
Sponsorship:Travel Requirements:Flexible Work Arrangements:Not
ApplicableShift:Valid Driving License:Hazardous
Material(s):SummaryLocation: CHN - Beijing - Beijing (Wangjing
Park)Type: Full time