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Specialist, Clinical Data Management

Requisition ID: CLI007931

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its¬ legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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Lead clinical data mapping and data management activities pertaining to clinical research trials that include but not limited to:



  • data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, and query management utilizing knowledge of SAS programming tools and techniques, to ensure that data collected adhere to and are in compliance with Merck Standard Operating Procedures (SOPs) and International Council for Harmonization (ICH)-Good Clinical Practice (GCP) guidelines

  • Execute clinical trial data mapping to provide data for reporting, Study Data Tabulation Model (SDTM) creation, and other downstream clinical applications and Reporting and Mapping (RaM) deliverables within clinical studies development including facilitating startup activities, database creation, database maintenances, change management, and database finalization.¬ 

  • Design clinical trial database to ensure the integrity of the data for inclusion in worldwide health registration are in accordance to Merck SOPs and reference manuals.¬ 

  • Support data flow and Global Clinical Database Standards (GCDS) implementation of standards, process and integration and implement Oracle Central Designer, Oracle's Data Management Workbench (DMW), Oracle's Life Sciences Data Hub (LSH) for data collection and processing in clinical trials.¬ 

  • Provide support to organization's Clinical Metadata Management System/End to End (CLMM/E2E).

  • Coordinating data management activities to achieve milestones; reviewing clinical study protocols, SOP and technical user manuals to ensure compliance with Merck SOPs and ICH-GCP guidelines; generating study of specific maplets, support CDR UAT runtime, support UAT of mapping tools; and developing programs for study specific derivations within the STDM domains, data quality listings and quality control check.¬ 

  • Other duties include providing support to company's Patient Data Acquisition and Management Next Generation (PDAM NG) system by designing, developing, testing and implementing applications utilizing Oracle DMW/LSH to provide an integrated data management application environment for external data, data collection, reporting and data analysis of Merck Clinical Trial System using Oracle's DMW/LSH Application for Trials.



Qualifications
Education:¬ 



  • Must have Master's Degree in Biology with concentration in Bioinformatics or Master's Degree in Computing & Information Science.



Qualifications:



  • Applicant must have knowledge of Statistical Analysis Systems (SAS) and Structured Query Language (SQL) tools such as: SAS/Base, SAS/STAT,SAS/SQL,SAS/MACRO,SAS/ODS,SAS/GRAPH and Oracle Clinical and SQL developer Databases.¬ 

  • Knowledge in Clinical Database Development/Transformations, including tools in support of this exercise (e.g., InForm, Data Loading, SQL, Java) and System Development Lifecycle Management/system validation required.¬ 

  • Thorough knowledge of SDTM/ADAM data models and CDISC standard, programming techniques (SAS), analytical ability, and sound professional judgment is required.¬ 

  • 40 hours per week 9:00a.m. - 5:00 p.m. Must have proof of legal authority to work in the United States.¬ 



Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.¬ 


If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

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Search Firm Representatives Please Read Carefully:¬ 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.¬  Please, no phone calls or emails.¬  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.¬  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

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Visa sponsorship is not available for this position.

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For more information about personal rights under Equal Employment Opportunity, visit:

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¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬  EEOC Poster

¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬  EEOC GINA Supplement


¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬  ¬ OFCCP EEO Supplement

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ‚€“ proudly embracing diversity in all of it's manifestations.



Job: Clinical Data Management
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 2
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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