Join Merck Group as a Specialist, Data Integration!

Ready to push boundaries and make groundbreaking discoveries? At Merck Group, we thrive on innovation in Healthcare, Life Science, and Electronics to enhance people's lives. Our global team shares a passion for science, technology, and innovation. If you're a curious mind eager to envision the unimaginable, we want you with us!

Your Role

As a Specialist, Data Integration, you will:

• Consult on system development, administration, and validation of Pinnacle 21 Enterprise, eClinical Solutions Elluminate, and other Clinical Data Repositories.
• Define, review, and approve risk mitigation plans to ensure GxP computerized systems comply with regulatory standards.
• Lead and manage validation efforts for all GxP systems, authoring validation documents and test scripts.
• Document and implement technical requirements for system validation.
• Collaborate with cross-functional teams to align system validation activities with business processes and user requirements.
• Champion the system during user acceptance testing (UAT) and ensure fitness for intended use.
• Implement and maintain procedural controls to uphold validated state and protect data integrity.
• Evaluate change requests affecting security, maintainability, and data integrity.
• Coordinate with vendors and internal stakeholders for successful GxP system validation.
• Provide subject matter expertise on validation processes and regulatory requirements.
• Perform system administration tasks for Pinnacle 21 Enterprise and optimize existing processes.
• Develop and execute system administration tasks for Clinical Data Repositories (e.g., eClinical Solutions: Elluminate).
• Manage user operations for DMMI systems, including setup, support, and documentation compliance.

Capabilities and Knowledge

Ideal candidates will possess:

• Excellent self-organizational and time management skills with keen attention to detail.
• Background knowledge in ICH-GCP, Computerized Systems Validation, and Operational System Management is a plus.
• Proficiency with clinical data management systems, especially Pinnacle 21 Enterprise.
• Outstanding command of English (both verbal and written); additional languages are a bonus.
• Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences) or equivalent experience.
• Extensive experience in validation processes within a GxP-regulated environment, particularly in pharmaceuticals, biotech, or medical devices.
• Strong understanding of GxP, GAMP 5, and FDA guidelines.
• Proven project management skills in validation, including documentation and test script authoring.
• Excellent communication and interpersonal skills for effective cross-functional collaboration.

Who You Are

We seek candidates with a degree in Life Sciences (e.g., biology, chemistry, pharmaceuticals) and 6-8 years of industry experience.

Diversity and Inclusion

We are an equal opportunity employer committed to diversity and inclusion. We value varied perspectives and life experiences, driving excellence and innovation. We ensure non-discrimination in employment on any basis, including race, caste, creed, color, religion, sex, age, disability, marital status, sexual orientation, and gender identity. Our inclusive culture empowers everyone to bring their best self to work each day.

What We Offer

Join a team of curious minds from diverse backgrounds, unified by our commitment to leading in science and technology. We celebrate all dimensions of diversity, believing it strengthens our innovation and ability to drive human progress. We provide access to opportunities for personal growth and development at your own pace. Let's build a culture of inclusion and belonging that impacts millions.

Apply now and become part of our diverse team!