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Digital Operations, QC Specialist II - CRG

ThermoFisher Scientific • Allentown, PA • 1h ago

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 opportunities to improve efficiency and processes.

Excellent attention to detail and a strong commitment to quality.

Demonstrated project management, communication, and organizational skills.

Strong collaboration skills and a positive, professional approach.

The ability to effectively manage a high-volume workload while meeting deadlines.

Confidence presenting information to management and stakeholders

The ability to apply professional concepts, company policies, and established procedures to resolve issues and deliver effective solutions.

At Thermo Fisher Scientific, we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position, which also includes the possibility of equivalent experience:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require as-needed travel (0-20%).

Location: Remote USA. Pacific and Mountain time preferred. Relocation assistance is NOT provided.

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