Specialist, Clinical Data Management - Hybrid

Merck; Rahway (NJ); Hybrid; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Rahway, NJ, invites applications for a QC/UAT Testing Specialist responsible for creating and executing testing procedures for electronic data capture systems, in-life data review reports, and clinical data management databases.

You will document results thoroughly, collaborate across functions to uphold database standards, and contribute to SOPs in line with ICH-GCP guidelines. A BS in a relevant field is required, with strong Python/Java/C#/SQL and data management skills.

Qualifications

• 2+ years of SDLC management / system validation knowledge.
• Database design and development knowledge.
• Working knowledge of clinical development processes.

Responsibilities

• Create and execute QC testing and UAT procedures for EDC, in-life data review reports, and clinical data management databases.
• Report and document testing results thoroughly.
• Collaborate with functional area representatives to ensure data standards and project-level consistency.
• Write standard and trial-specific test scripts and provide peer reviews of UAT documentation.

Skills

Python

Java

C#

Jira

Power BI

Github

SQL

SDLC knowledge

Communication

Database design

Education

B.S. degree in mathematics/science or CS

Tools

Jira

Power BI

Github

SQL

Job description

Job Description

• Responsible for the creation and execution of Quality Control (QC) Testing and User Acceptance Testing (UAT) procedures for electronic data capture systems, in-life data review reports, and clinical data management databases. This includes: Internet-based EDC, Electronic devices, Electronic diaries and COA/IVRS/IWRS.
• Reporting and documenting testing results thoroughly and accurately is required.
• Partners with functional area representatives to ensure appropriate use of database standards and project-level consistency on database, data collection, review, and retrieval specifications.
• Additionally, the individual may be responsible for writing standard and trial-specific test scripts and providing peer reviews of User Acceptance Testing documentation.
• All activities will be conducted in compliance with our Company's Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

Key Responsabilities:

• Responsible for the creation and execution of Quality Control (QC) Testing and User Acceptance Testing (UAT) procedures for electronic data capture systems, in-life data review reports, and clinical data management databases. This includes: Internet-based EDC, Electronic devices, Electronic diaries and COA/IVRS/IWRS.
• Reporting and documenting testing results thoroughly and accurately is required.
• Partners with functional area representatives to ensure appropriate use of database standards and project-level consistency on database, data collection, review, and retrieval specifications.
• Additionally, the individual may be responsible for writing standard and trial-specific test scripts and providing peer reviews of User Acceptance Testing documentation.
• All activities will be conducted in compliance with our Company's Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

Education

• B.S. degree, preferably in mathematics, science, a health care related discipline, or computer science.

Knowledge And Skills

• 2+ Years of System Development Lifecycle Management / system validation knowledge.
• Database design and development knowledge.
• An overall working knowledge of the clinical development process.
• Knowledge of database structures and available tools to manage, extract, and report data is preferred.
• Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
• Exceptional organizational and problem-solving skills.
• Ability to work cross functionally and as part of a team.
• Able to work under pressure and change environment with flexibility.
• System Development Lifecycle Management / system validation knowledge.
• Knowledge of Python, Java, C#, Jira, Power BI, Github, SQL.

Required Skills

Clinical Data Management, Data Analysis, Database Development, Data Processing, Data Quality Assurance, Data Validation, Data Visualization, Electronic Data Capture (EDC), Learning Agility, PL/SQL (Programming Language)

Preferred Skills

Collaboration, Communication, Teamwork

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$87,300.00 - $137,400.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search 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

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

No

Job Posting End Date

10/22/2026

• 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.

Requisition ID: R421847