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Clinical Data Manager
Job Description: Clinical Data Manager – Hybrid, Crawley, West Sussex
About Theradex Oncology
Celebrating 40+ years of experience! Theradex Oncology is a full-service contract research organisation (CRO), specialising in oncology. We manage global oncology trials and programs, originating from our 1982 partnership with the National Cancer Institute. Since then, we’ve expanded to support industry sponsors developing cancer therapeutics via early and late-phase trials.
As part of Theradex Oncology, you’ll join one of the largest professional teams dedicated entirely to advancing cancer therapy development. In this evolving field, your contributions will play a crucial role in progressing new treatments and therapeutic approaches. We foster a dynamic environment for highly motivated individuals ready to make an impact.
The Opportunity: Clinical Data Manager (Hybrid, UK)
Position Details
- Location: Hydrbrid role with minimum 1 day in-office at our Crawley, West Sussex office. Candidates ideally located near Gatwick Airport or within the London commute zone, with access to motorway/rail networks.
Key Responsibilities
Your role will centre on people-first data management, ensuring efficiency and compliance across multi-phase oncology trials. Key tasks include:
- Compliance & Governance
- Execute all Clinical Data Management (DM) activities in line with SOPs and ICH-GCP.
- Oversee design adherence to CDISC (CDASH/SDTM) standards for data transfer.
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Cross-Team Collaboration
- Lead multi-study DM operations (moderate complexity) with limited supervision.
- Liaise with SAS programming, biostatistics, and data management leads—acting as the primary study DM contact.
- Engage with CRAs and project teams to address and remediate data gaps/issues.
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Study Start-Up & Execution
- ECRF development, programming, and Embedded Data Capture (EDC) builds.
- Draft and validate Data Listing Development tools.
- Facilitate eCRF completion guidelines and train sites on instance completion.
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Project Support & Quality Assurance
- Maintain Data Management Plans (DMPs) and Data Transfer Agreements (DTAs).
- Conduct eCRF UAT (User Acceptance Testing) and database validation programs.
- Lead SAS/Excel scripts for study metrics, clinical review, and data quality.
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Field & Coding Expertise
- Perform WHO Drug Dictionary and MedDRA coding for safety/efficacy identification.
- Conduct databasing + data reviews to validate all patient-level data.
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Reporting & Documentation
- Generate monthly project status reports and sponsor-requisite listings.
- Create ad-hoc reports for urgent data queries.
- Ensure Trial Master File (TMF) compliance and audit-readiness at all times.
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Training & Process Improvement
- Mentor junior team members (as needed).
- Streamline workflows to enhance project efficiency.
Requirements
Education & Experience
- Bachelor’s degree (Master’s degree preferred in Data Science, Clinical Research, or related field).
- 3 years minimum of CRO/pharmaceutical industry experience in Clinical Data Management.
- eCRF design experience required (preference for RAVE EDC familiarity).
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Core Skills & Qualifications
- Demonstrated knowledge of GCP guidelines and protocol comprehension.
- Strong SAS/VBA/SQL programming (or other clinical domain languages).
- CDISC (E2B/CDASH/SDTM) compliance established via practical application.
- Proactive problem-solving, prioritising data integrity and timelines.
- Project management ability to multitask without losing consistency on deadlines.
- Technical communication—confident in explaining medical/technical details clearly.
- Grammar and digital communication: Fluent in written/verbal English.
- Word/Excel proficiency and basic HDFS-FTP understanding.
Compensation Package
We provide: ✔ Competitive compensation reflective of expertise level. ✔ 6% employer pension contribution. ✔ Private medical insurance coverage. ✔ In sickness absence, sick/gap pay, and income protection plan. ✔ Comprehensive life assurance. ✔ Access to an eyecare voucher scheme. ✔ Employee Assistance Program for work-life balance support.
Theradex Oncology values diversity and is an equal opportunity employer. We encourage applications from all qualified candidates and will consider all applicants for employment.
Important Note: This position does not offer company-sponsored visas.
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