Job Description

Create, review, and facilitate approval of external data format specification documents including, but not limited to; Data Transfer Specifications (DTS), Electronic Data Transfer (eDT), for new service providers and data types.

Coordinate with external and internal service providers, Information Technology (IT), and the other supporting functions to validate external data transfers into the data management system in accordance with detailed transfer specifications.

During the in-life portion of a study, and in preparation for interim and end-of-study database locks, execute and review output of assigned reports to ensure completeness of data transfers; communicate and resolve external data loading issues with service providers and IT, as appropriate.

Education: B.A. or B.S. degree, or advanced student, preferably in Medicine, Biochemistry, Pharmacy, Nursing, Bioengineering, Biological or Computer Sciences, or health care related discipline.

Knowledge and Skills:

1. 0 to 1 year experience in data management, medical research, or database design and development.

2. Knowledge of the clinical development process; database structures and available tools to manage, extract, and report data are preferred.

3. Very good communication skills (oral and written) with the ability to communicate with both technical and business areas and external vendors.

4. Very good organizational and problem-solving skills.

5. Ability to establish and maintain good working relationships with different functional areas.

6. Ability to work independently under pressure and adapt to changing environments.

7. Sense of urgency and customer focus.

8. Desire and ability to learn new processes and technologies.

9. Knowledge of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11 are preferred.

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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):

Required Skills:

Adaptability, Analytical Problem Solving, Clinical Data Cleaning, Clinical Data Management, Data Analysis, Data Documentation, Data Entry, Data Processing, Data Reporting, Data Review, Data Validation, Data Visualization, Good Clinical Practice (GCP), IS Audit, Report Writing, Root Cause Analysis (RCA), Teamwork, University Education

Preferred Skills:

Job Posting End Date:

09/23/2025

*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.