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Quality Assurance (GCP) Manager at The Fusion Group
London, London - England, United Kingdom -
Full Time

Start Date

Immediate

Expiry Date

17 Jan, 27

Salary

40000.0

Posted On

19 Oct, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Industry

Hospitals & Health Systems

Description
  • Data Management Study Participation: Conduct all clinical data management activities, including data collection, validation, cleaning, medical coding and reconciliation processes.
  • Data Management set-up: Contribute to the design, development, and review of Case Report Forms, Data Management and Data Review Plans and other study set up activities.
  • Data Validation & Quality Control: Take responsibility for the execution of data validation activities to ensure data consistency, accuracy, and completeness, EDC checks, data listings and other data review tools to ensure data integrity.
  • Vendor Data: Manage receipt and reconciliation of external data, ensuring deliverables meet quality, regulatory, and timeline expectations.
  • Issue Resolution & Support: Troubleshoot data-related issues and provide hands-on support to internal and external stakeholders.
  • Cross-Functional Collaboration: Work closely with clinical operations, biostatistics, and programming teams to align data management activities with overall study objectives.
  • Documentation: Ensure that documentation required to demonstrate regulatory compliance are maintained accurately.
  • Regulatory Compliance: Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements (FDA, EMA).
  • Study Review & Reporting: Participate in data review meetings, contribute to database lock, and support clinical study report preparation.
  • Industry Best Practices: Stay up to date with emerging trends and best practices in clinical data management.
  • Skills and Experience RequiredBachelor's degree in Life Sciences, Biotechnology, or a related field.
  • Proven experience in clinical data management within a biotech, pharmaceutical, or CRO environment.
  • Hands-on expertise with key clinical data management systems.
  • Knowledge of Good Clinical Practice (GCP), ICH guidelines, and global clinical trial regulations.
  • Excellent logical, analytical and problem-solving skills with a creative and curious approach to help drive innovation.
  • Good customer focus, able to prioritise the needs and satisfaction of our customers and deliver quality data.
  • Ability to work both independently and collaboratively in a fast-paced, cross-functional environment, and to hold yourself and others to account for appropriate ethical behaviour and inclusivity.
  • Dependable and a commitment to maintaining high data quality standards through a conscientious approach.
  • This role is ideal for an clinical data professional established with all data management activities who thrives in a collaborative environment and is passionate about advancing clinical research through high-quality data management practices.
Responsibilities