Digital Operations, QC Specialist II

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Oversee the quality control process for global clinical study configurations and manage quality checks at the study level, which includes documentation, communication, risk identification, SOP compliance, and adherence to timelines.

• Evaluate financial CTMS, eSource, and other study configurations to ensure alignment with protocol, budget, site network, and regulatory requirements.

• Identify, investigate, and resolve issues related to technical aspects and configurations.

• Collaborate with study builders to gain insight into build design and study requirements prior to QC activities.

• Work alongside builders, customers, and stakeholders to address configuration inquiries and quality issues.

• Relay study-level quality findings and coordinate resolutions with managers and collaborators.

• Seek opportunities to enhance efficiency, quality, and processes, and assist in leading implementation efforts.

• Collaborate with various departments on client audits, CAPAs, and procedural documentation.

• Analyze moderately complex problems and determine appropriate solutions using sound judgment.

• Present information to management and stakeholders while managing a high-volume workload and meeting deadlines.

⛳️ Requirements

• Bachelor’s degree or an equivalent relevant formal academic or vocational qualification.

• Prior experience in technical QC or technical build, typically equivalent to 5 years.

• Familiarity with ICH-GCP, FDA, and other relevant regulatory guidelines.

• Preferred experience with medical terminology, clinical research protocols, clinical study budgets/contracts, and study documentation.

• Comprehensive understanding of study configuration processes.

• Strong judgment, decision-making, analytical, and problem-solving skills.

• Capability to work independently and adapt to rapidly changing priorities.

• Excellent organizational and time-management abilities.

• Proficiency in using and learning software and systems for organizing information and generating reports.

• Mindset geared towards continuous improvement and the ability to identify efficiencies and process enhancements.

• Exceptional attention to detail and a commitment to quality.

• Proven project management, communication, and organizational capabilities.

• Strong collaboration skills with a positive and professional demeanor.

• Ability to manage a high-volume workload while adhering to deadlines.

• Able to present information confidently to management and stakeholders.

• Skill in applying professional concepts, company policies, and procedures to resolve issues.

• Proficient in communicating, receiving, and understanding information with diverse groups.

• Capability to work upright and stationary during standard working hours.

• Proficient in using and learning standard office equipment and technology.

• Ability to perform under pressure while prioritizing and managing multiple projects.

• Must be legally authorized to work in the United States without sponsorship.

• Must successfully pass a comprehensive background check, including drug screening.

• May require occasional travel of 0-20%.

🏝️ Benefits

• Fully remote work arrangement.

• Eligibility for a variable annual bonus based on company, team, and/or individual performance outcomes.

• Occasional travel may be required (0-20%).

• Reasonable accommodations for individuals with disabilities during the application, interview, and job functions.

• Comprehensive benefits and privileges associated with employment.