Digital Operations, QC Specialist II - CRG

Job Title: Digital Operations, QC Specialist II - CRG

Job Location: Remote, Pennsylvania, USA

Job Location Type: Remote

Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri) Environmental Conditions
Office Job Description

About us :

At Thermo Fisher’s PPD clinical research business (CRG), we’re using digital innovation, data science, and AI to reimagine how life-changing therapies reach patients. Our teams combine deep scientific expertise with advanced analytics, automation, and digital platforms to make research smarter, faster, and more connected.

You’ll join a culture that values experimentation, learning, and collaboration — where your ideas can help shape how we deliver life-saving solutions and improve global health outcomes. Whether you’re a data engineer, product manager, software developer, or AI scientist, you’ll find opportunities here to apply your skills to work that truly matters — improving global health outcomes.

About the Role:
As a Digital Operations QC Specialist II, you’ll play an important role in ensuring the quality and accuracy of clinical study configurations. Serving as a subject matter expert for quality control activities within the clinical study build process, you’ll partner with study builders, system teams, customers, and other collaborators to ensure configurations meet protocol, operational, and regulatory requirements.

You’ll also help lead QC activities during technology implementations, identify opportunities to strengthen our processes, and contribute to continuous quality improvement across the organization.
A Day in the Life:

- Coordinate the global clinical study configuration QC process and manage study-level quality checks, including documentation, communication, risk identification, SOP compliance and timeline adherence.

- Review study configurations (finance CTMS, eSource, other) to ensure they accurately reflect protocol requirements, study budgets, and site network needs while complying with regulatory guidelines.

- Identify, investigate, and resolve technical and configuration-related issues.

- Partner with study builders to understand build design and study requirements before initiating QC activities.

- Collaborate with builders, customers, and other stakeholders to resolve configuration questions, uncertainties, and quality findings.

- Communicate study-level quality findings and coordinate appropriate resolutions with managers and collaborators.

- Identify opportunities to improve efficiency, quality, and processes, and help lead the implementation of those improvements.

- Partner across departments to maintain quality, compliance, and timelines for activities such as client audits, CAPAs, and procedural documentation.

- Analyze problems of moderate scope, using sound judgment to evaluate multiple factors and determine appropriate solutions.

Education:
- Bachelor’s degree or equivalent relevant formal academic or vocational qualification.

Experience:

- Previous technical QC or technical build experience (comparable to 5 years) that provides the knowledge, skills, and abilities required for the role.

- Experience working with ICH-GCP, FDA, and other applicable regulatory guidelines.

- Experience with medical terminology, clinical research protocols, clinical study budgets/contracts, and study documentation is preferred.

Knowledge, Skills & Abilities:

- In-depth knowledge of study configuration processes.

- Strong judgment and decision-making skills.

- Excellent analytical and problem-solving abilities.

- The ability to work independently and adapt to rapidly changing priorities.

- Strong organization and time-management skills

- The ability to use software and systems to organize information and produce reports, including the ability to learn and retain knowledge of applications used to develop study configurations for clinical sites.

- A continuous-improvement mindset and the ability to identify opportu