QC Specialist

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.

We employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it.

People join Quotient Sciences because we are a respected member of the drug development community that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

The Role

• Supports Clinical Manager to ensure data integrity during study set up and data collection
• Timely reviews source data collected for data integrity and compliance with Good Documentation Practices and relevant SOPs
• Reconciles source data collected on paper with eSource comments and entries
• Works with the clinic and project management departments to ensure that qc and query resolution timelines are being met
• Works with Clinical Manager to implement measures to uphold data integrity
• Complies & adheres to GCP guidelines and regulations as required of this role.
• Ensures study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards.
• Ensures subject safety at all times
  
  

Main Tasks And Responsibilities

• Serves as support for Clinical Manager to ensure studies are set up for successful and high-quality data collection
• Understands clinical protocols and requirements for data collection
• Performs real-time QC checks on critical data as assigned by Clinical Manager
• Ensures proper QC checks are performed on all clinical data for data integrity, particularly looking for incomplete or implausible data
• Resolves queries as per scope and coordinates resolution of queries requiring other clinical parties
• Ensures queries are addressed and resolved by the appropriate parties; assists as needed
• Identifies discrepancies in source documentation and works with clinical staff for corrections and/or explanations.
• Promptly reports any evidence or suspicion of fraudulent data collection or documentation
• Evaluates query responses in eSource. May reissue query as necessary and re-train staff as appropriate
• Reports/records protocol deviations encountered during review of clinical data
• Ensures paper sources are transcribed appropriately and timely into the eSource capture system
• Assists with QC of study activity schedules against the eSource build during study start up
• Prepares the initial template for lab tracking and ensures lab tracking is up to date.
• Works collaboratively with the Clinical Leads during study start up to plans for high quality data collection for all studies
• Works with the Project Management team to ensure the timelines are being met for QC and query resolution
• Assists with retrospective review of clinical data, e.g. in quality deviation investigations, upcoming audits, etc.
• Assists with activities to support validation of clinical systems
  
  

The Candidate

• Minimum 2 years’ relevant experience in a clinical environment or equivalent experience in another role
• Proficient in the use of Microsoft Office packages including Word, Excel...etc.
• Attention to detail and organizational skills required
• Able to assume increasing levels of responsibility and perform effectively
• Able to plan, coordinate, organize, and prioritize to meet deadlines
• Able to interact successfully with team members and study participants
• Self-directed - able to perform with minimal supervision
• Able to read and understand protocols
  
  

This Job posting will expire on January 17, 2025.

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.