RDL Scientific are offering an exciting opportunity to join a science-led global pharmaceutical company as a Data Checker based in Addenbrooke’s Hospital, Cambridge.
The Clinical Unit Cambridge (CUC) undertakes First Time in Human (FTIH), Phase 1 and Experimental Medicine clinical trial studies. The Data Checker plays a vital role in ensuring the integrity, accuracy and compliance of clinical trial data in accordance with ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) principles. This position is responsible for conducting Quality Control (QC) checks on study documentation and collaborating with a multifunctional study team to maintain data integrity at a high standard throughout the clinical trial, in addition to complying with the study protocol, ICH-GCP, GDPR, regulatory standards, ethical requirements and other internal guidelines, such as Standard Operating Procedures (SOPs).

Key Responsibilities:

• Perform QC checks on clinical trial data to ensure accuracy, completeness and compliance with ALCOA principles, GCP and regulatory standards, and contribute to the inspection readiness of study documentation.
• Review study documentation, including Case Report Forms (CRFs), source documents, and electronic data, to identify discrepancies to ensure data consistency and appropriate version control.
• Work closely with multidisciplinary study teams, including the Principal Investigator, Recruitment Coordinators and clinical staff, to resolve data queries and discrepancies.
• Ensure all data corrections are properly documented and GCP compliant.
• Management and preparation of QC documents and other clinical trial related documentation or study forms.
• Monitor and analyse data queries to identify trends, develop strategies to reduce recurring issues, and provide feedback on best practices for data quality to relevant stakeholders.
• Support the development and implementation of quality control processes to enhance efficiency and accuracy. Provide feedback and recommendations to improve data collection and documentation processes.
• Maintain confidentiality and security of clinical trial data in compliance with GCP, GDPR and other regulatory requirements.
• Inputting of clinical trial data into electronic systems and databases.
• Support with archiving of clinical trial documentation as required.
• Assist with the maintenance of the Investigator Site File.
• Leading or contributing to workstreams, non-study related projects or written standard updates to support process implementation and improvements.
• Support ad-hoc administrative and clinical operations tasks as required.
• Responsible for completing all mandatory training in a timely manner and proactive in maintaining compliance with training standards.

Qualifications/Characteristics:

Required:

• Educated to A level standard or equivalent.
• Experience working within an ICH-GCP environment (or similar).
• Strong understanding of Good Documentation Practice.
• Good computer skills and proficiency in using Microsoft Office, Word and Excel.

Preferred:

• Experience in a healthcare or clinical trial setting.

Other job related skills:

• Strong attention to detail and excellent organisational skills.
• Professionalism and proactive attitude, demonstrating initiative, discretion, and diplomacy.
• Excellent communication, both verbal and written, and strong interpersonal skills.
• Proven ability to work effectively within a team and adopt a collaborative mindset.
• Technical proficiency with the ability to champion and implement new technology as required.
• Capable of prioritising workloads and managing diverse tasks efficiently.
• Adaptable and flexible in handling change within a fast-paced environment.
• Skilled at working under pressure and meeting tight deadlines.
• Self-motivated with strong business awareness and sensitivity to confidential information.

Job Types: Full-time, Permanent
Pay: From £24,000.00 per year

Benefits:

• Company pension
• Life insurance
• Private medical insurance
• Sick pay

Work authorisation:

• United Kingdom (required)

Work Location: In perso

• Perform QC checks on clinical trial data to ensure accuracy, completeness and compliance with ALCOA principles, GCP and regulatory standards, and contribute to the inspection readiness of study documentation.
• Review study documentation, including Case Report Forms (CRFs), source documents, and electronic data, to identify discrepancies to ensure data consistency and appropriate version control.
• Work closely with multidisciplinary study teams, including the Principal Investigator, Recruitment Coordinators and clinical staff, to resolve data queries and discrepancies.
• Ensure all data corrections are properly documented and GCP compliant.
• Management and preparation of QC documents and other clinical trial related documentation or study forms.
• Monitor and analyse data queries to identify trends, develop strategies to reduce recurring issues, and provide feedback on best practices for data quality to relevant stakeholders.
• Support the development and implementation of quality control processes to enhance efficiency and accuracy. Provide feedback and recommendations to improve data collection and documentation processes.
• Maintain confidentiality and security of clinical trial data in compliance with GCP, GDPR and other regulatory requirements.
• Inputting of clinical trial data into electronic systems and databases.
• Support with archiving of clinical trial documentation as required.
• Assist with the maintenance of the Investigator Site File.
• Leading or contributing to workstreams, non-study related projects or written standard updates to support process implementation and improvements.
• Support ad-hoc administrative and clinical operations tasks as required.
• Responsible for completing all mandatory training in a timely manner and proactive in maintaining compliance with training standards