An exciting opportunity to join Veramed's Data Management Business Unit! As we continue to grow and build on our success, we're looking to recruit a passionate and driven Senior Clinical Data Manager. You'll be required to have strong and indepth expereince of Data Management Study Start Up, Medidata Rave (including eCOA) and experience of vendor management and EDC Build management. This role can be based in our UK offices or a hybrid working model.

Veramed prides itself on two key areas: providing the highest quality Data Management, Statistics and Programming consultancy for its clients, and giving its employees an industry leading working environment with support and training for career growth.

Purpose:The role of the Senior Clinical Data Manager is to provide data management support to the data management department across a range of projects, sponsors and therapeutic areas. Provide expertise and manage the start up of new data management studies.

Key Responsibilities:The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.

• Technical:Review of clinical protocols
• Create or review Case Report Forms for data collection and compare with the protocol to ensure consistency
• Create or review Edit Check Specification document
• Preparation of UAT documentation and perform UAT of EDC and communication of findings
• Creation of study specific documents such as Data Management Plan, Data Review Plan, eCRF Completion Guidelines, etc.
• Create or review specifications for data review listings and / or customized reports to facilitate data cleaning
• Ongoing review of data entered in EDC to ensure the data is clean for analysis
• Issue queries to clinical monitors or investigational sites as appropriate
• Resolve standard queries
• Perform medical coding
• Work with external vendors on data transfer agreements / specifications
• Ensure external data is reconciled as required
• Track queries and data cleaning activities to ensure ongoing review of data entered is completed and data is fit for analysis.
• Maintain study master file documents and any other documents that are required to be audit ready
• Work in accordance with internal (or sponsor, where applicable) SOPs and procedures

• Project Management:May serve as the main contact for the sponsor
• Awareness of study budget and proactive identification of scope changes
• Ensure key project milestones are delivered on time with the highest quality
• Maintain timelines and communicate risks / updates to the Data Management Project Manager
• Collaborate with cross-functional team members to ensure that the study deliverables are provided on time and with quality

aAbout the job

Clinical Data Manager – Clinical Trials / Real-World Evidence

Location: UK / RemotePermanent

KEMIO is looking for an experienced Clinical Data Manager to join a growing Healthcare and Data Analytics Life Sciences organisation delivering observational clinical studies and real-world evidence programmes, with a particular focus on oncology and rare disease.

This is a hands-on role where you'll take ownership of clinical data management activities across Phase II–IV studies, working closely with Clinical Operations, Biometrics, Data Science and Sponsor teams.

What you'll be doing

• Develop and maintain Data Management Plans (DMPs) and data validation specifications• Support eCRF/EDC design and clinical database development• Lead data review, cleaning, validation and site query management• Manage clinical coding including MedDRA and WHO Drug• Support adverse event/SAE reconciliation and safety data requirements• Work with multiple data sources including eCOA/ePRO, laboratory, biomarker, EHR, omics and wearable data• Coordinate data transfers and integrations• Manage activities through to Database Lock• Produce data management metrics and KPIs• Work closely with internal teams and external Sponsors to ensure high-quality, compliant data delivery

What we're looking for

You'll have 5+ years' clinical data management experience, ideally gained within pharma, biotech, CRO or a clinical research environment.

• You'll bring strong experience across:• Phase II–IV clinical studies• Clinical data review, cleaning and validation• EDC/eCRF design and edit checks• Site query management• MedDRA and WHO Drug coding• Safety data and SAE reconciliation• Taking clinical databases through to database lock• Working within ICH-GCP and relevant regulatory requirements