Proclinical is seeking a Contract Clinical Data Manager to support oncology-focused clinical trials. In this role, you will oversee the quality and integrity of clinical trial data, ensuring compliance with regulatory standards, internal SOPs, and industry best practices. This is a 6-month contract role, primarily remote, with occasional travel to London or Egham, Surrey, as needed.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
* Design, set up, and validate EDC systems, including defining and maintaining eCRFs, edit checks, and data management plans.
* Collaborate with CRO partners on database build, validation plans, and data transfer specifications.
* Perform ongoing data review, validation, and query management to ensure data accuracy and completeness.
* Reconcile data across multiple sources, including EDC, safety, labs, imaging, and pharmacovigilance, and support SAE reconciliation.
* Manage medical coding of adverse events, medical history, and medications using MedDRA and WHODrug.
* Ensure compliance with CDISC-CDASH-SDTM standards and internal guidelines.
* Act as the primary Data Management contact for studies, liaising with internal teams, CROs, and site staff.
* Support data preparation for DMCs, interim analyses, and database lock activities.
* Maintain audit-ready documentation and ensure adherence to ICH-GCP, 21 CFR Part 11, and company SOPs.
* Author and maintain Data Management-related SOPs.
Key Skills and Requirements:
* Bachelors degree in Life Sciences, Computer Science, Data Science, or a related field (Masters preferred).
* Proficiency in coding dictionaries such as MedDRA and WHODrug, with familiarity in CDISC-CDASH-SDTM standards.
* Strong understanding of drug development phases (I-IV) and clinical trial processes.
* Experience in clinical data programming and the ability to review and evaluate clinical data.
* Excellent communication, problem-solving, and organizational skills.
* Agile thinker with a growth mindset and the ability to adapt to high-speed changes.
* Results-oriented with strong strategic thinking and planning capabilities.
* General data management skills, including maintaining GxP compliance and following standard operating procedures.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click Apply or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that youve read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy