Job Description
Activities may include, but are not limited to:
- Build, integrate, and maintain clinical databases and study systems, including transformations, edit checks, reporting, and user testing, while supporting governance of cross‑study programming environments.
- Design, develop, test, and maintain clinical technology systems (EDC, RTSM, eCOA/ePRO) using programming and automation frameworks.
- Implement and validate complex data logic such as rules, derivations, and dynamic rules.
- Propose and develop tools to streamline design, build, and validation workflows.
- Apply data literacy to convert collected data into actionable insights.
- Develop advanced reporting solutions, including dashboards and visual analytics, using enterprise platforms.
- Configure, test, and validate data sources for integrations and transformations across systems.
- Collaborate with stakeholders to translate business needs into technical and system requirements.
- Troubleshoot routine data ingestion and consumption issues, escalating non‑standard problems appropriately.
- Develop robust data models, semantic layers, and curated datasets while monitoring pipelines and enforcing quality checks.
- Validate system functionality and ensure adherence to SOPs, regulations, and compliance standards.
- Identify process gaps and contribute to continuous improvement initiatives.
- Maintain audit‑ready documentation for changes, incidents, and system updates.
- Mentor junior colleagues and contribute to onboarding and knowledge sharing.
- Support release management activities, including change control and risk assessment.
- Lead UAT activities, translate requirements into technical specifications, and refine reporting standards.
- Communicate data and technical findings clearly and partner across teams to enable coordinated, high‑quality delivery.
Education
- B.A. or B.S. degree (or current student), preferably in Biotechnology (primary focus). Candidates from Computer Science, healthcare‑related disciplines, or those with relevant skills and experience may also be considered.
Experience
- Minimum of 3 years experience working in database configuring, data engineering or data management operations, or 1+ years of specific experience in clinical database programming and upstream/downstream clinical data model configuring
Technical Skills
- Proficiency in multiple programming languages (SQL, Python, SAS, R) for implementing data collectors, integrations, transformations, and reporting.
- Skilled with key data‑management tools and platforms, with the ability to adopt new technologies with guidance.
- Able to execute technical tasks independently on straightforward work, seeking moderate guidance for non‑standard activities.
- Experienced in scripting and automating data ingestion, cleaning, and reporting processes.
- Strong understanding of clinical data flow across the study lifecycle (collection, processing, review, reconciliation, reporting).
- Familiarity with clinical and regulatory data standards, clinical operations, and typical clinical trial data structures.
- Knowledge of SDLC and validation practices, including change control, release checklists, and traceability.
- Understanding of GCP, data integrity, audit‑ready documentation, and UAT/sign‑off procedures.
- Experience optimizing reporting performance and applying data quality controls.
- Ability to link business needs to technical deliverables using standard procedures.
- English proficiency of at least C1 level.
Soft Skills
- Prioritizes tasks, meets deadlines, and maintains clear, organized documentation.
- Communicates effectively with technical and business partners, adapting style to the audience.
- Works independently with minimal guidance, using data to triage issues and proactively flag risks with recommended options.
- Collaborates well across functions, facilitates small working sessions, and follows through on action items.
- Builds strong cross‑functional relationships and remains open to feedback.
Required Skills:
Adaptability, Clinical Data Cleaning, Clinical Data Management, Customer-Focused, Data Analysis, Database Development, Data Processing, Data Quality Assurance, Data Review, Data Validation, Data Visualization, Electronic Data Capture (EDC), Learning Agility, Pharmacovigilance, PL/SQL (Programming Language)
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
06/12/2026
*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.