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北京市, 中国
Onsite
Not Available
Job Description
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:
40% Oversees and coordinates data mapping activities for multiple clinical programs. Interfaces with RaM manager to assure consistency of technical and process strategies. Acts as a technical resource to other members of the group. Plans appropriately to ensure adherence to timelines. Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
20% Creates and develops mapping specifications to meet SDTM structure requirements utilizing CLMM and E2E visibility tools to ensure quality and timeliness of data flow to the Clinical Data Repository. Ensures adherence to clinical database standards, SDTM structures, SOPs, and Process Guidelines. Leads and participates in the review of eCRFs, maplet development, transformation logic, and scripts to aid in the flow of data to the Clinical Data Repository in support of Analysis and Reporting performed by Scientific Programming.
20% Trains new hires and participates in the interview process. Provide ongoing training and development to RaM Mapping Programmers on existing standards. Helps to develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings.
15% Leads and participates in extra activities including, but not limited to, task forces,
testing of new systems and helps coordinate RaM technical initiatives. Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group. Provides ongoing mapping support to other departments. 5% Assist RaM Manager/Associate Director in project planning, manpower projections and resource allocations across therapy areas. Interface with RaM Manager/Associate Director to assure consistency of technical and process strategies across all therapy areas.
1. At least B.A. or B.S. degree, preferably in computer science, mathematics, science, or a health care related discipline.
Knowledge and Skills:
1. 5+ years’ experience with
a. CDISC Standards, (SDTM, CDASH, Define.xml)
b. SQL, PL-SQL, XML, Java.
c. ELT tools, preferably Contivo.
2. 3 years’ experience in Clinical Database Development/Transformations, including tools in support of this exercise (e.g., InForm, Data Loading, SQL, PL-SQL, Java, Contivo)
3. 2 years’ experience in System Development Lifecycle Management / system validation knowledge
4. An overall working knowledge of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.
5. Knowledge of database structures and available tools to manage, extract, report and warehouse data.
6. Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
7. Exceptional organizational and problem-solving skills.
8. Ability to work cross functionally and as part of a team.
9. Able to work independently, under pressure and change environment with flexibility.
Required Skills:
Adaptability, Clinical Data Management, Clinical Research, Communication, Data Analysis, Data Quality Assurance, Data Reporting, Data Review, Data Validation, Good Clinical Practice (GCP), Medical Terminology, Project Coordination, Teamwork, Vendor ManagementPreferred Skills:
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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:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
noJob Posting End Date:
09/30/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.