Job Description

Requirements

Education: B.A. or B.S. degree, preferably in IT, mathematics, science, a healthcare-related discipline, or computer science; or relevant skills and experience.

Language: English Business Proficient

Qualifications, Skills & Experience

Skills & Experience

Knowledge of database structures and available tools to manage, extract, report, and warehouse data.Desirable knowledge of database structures and available tools to manage, extract, report, and warehouse data (SQL-PL/SQL scripting).Desirable 2 years of database development or data programming experienceDesirable technical proficiency in a Clinical Data Management Systems (i.e., InForm, Inform Architect, Central Designer).2+ years’ experience in System Development Lifecycle Management / system validation knowledge.Desirable experience with reporting tools such as SAS, Cognos or JReview.Desirable experience in eCRF generation for site documentation and downstream regulatory compliance deliverables.Ability to collaborate and communicate with cross functional stakeholders to interpret and ensure quality report specifications and input to report development.Solid knowledge of MS Windows/Office software and exposure to web-based applications.Effective communication skills (oral and written) with the ability to communicate with both the technical and business areas.Strong organizational and critical thinking skills.Keen sense of urgency and customer focus.Ability to work cross functionally and as part of a team.Able to work independently, under pressure and change environment with flexibility.

Activities may include, but are not limited to:

Creates and develops clinical databases and data transfer files according to written specifications. Participates in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS). Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.Responsible for reporting deliverables supporting data cleaning and verification and any external data captured in clinical studies.Creates and reviews reporting specifications to ensure high quality deliverables, meet SDTM structure requirements and the needs of the business. Participates in the review of standard and template reports, and scripts to aid in the review of data to ensure a quality database.Participate in database Archiving and Decommissioning activities in support of multiple clinical programs (with Vendors interaction).

Participates in the following activities:

Interface with members of study teams and key stakeholders, to integrate requirements into all deliverables.Ensures adherence to clinical database standards, SDTM structures, SOPs, and Process Guidelines.Participates in activities including, but not limited to, task forces, testing of new systems and helps coordinate technical initiatives.

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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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/17/2025

*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.

Requisition ID:R328297