Warman O'Brien
Senior Clinical Data Manager
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Senior Clinical Data Manager (100% Home-Based / Remote, UK)
Company: Leading Global CRO
Location: Remote (Home-based anywhere in the UK)
Employment Type: Full-time
About the Opportunity
- Say Goodbye to Assembly-Line Burnout: Escape the hyper-fragmented, siloed environment of giant conglomerates. Here, you will lead tight-knit project teams with true database ownership.
- Industry-Leading Stability: Our clients boasts an exceptionally high employee retention rate, offering an incredibly supportive, stable environment where your voice is heard.
- Uncompromised Quality: Join a company celebrated for operational pride, featuring a flawless track record of zero technical validation findings across hundreds of global health authority submissions (FDA, EMA, Health Canada).
- True Flexibility: Enjoy a mature, fully remote work-from-home infrastructure designed to support a healthy work-life balance.
Key Responsibilities
- Lead Data Management, Training & Client Relationships:
- Project Ownership: Act as the primary day-to-day contact and ultimate owner of all data management deliverables, timelines, and status reports for assigned projects.
- Client & Scope Management: Serve as the first line of contact for technical, procedural, or out-of-scope discussions, participating in project kick-offs, investigator meetings, and bid defenses.
- Team Leadership & Training: Plan study-level resources (including timesheet reviews) and mentor junior staff. You will deliver training on EDC systems, dataflow, and QC processes to internal staff and clinical trial personnel.
- Compliance & Audits: Maintain clinical trial Data Management Study Binders and provide front-line support during client audits and regulatory inspections.
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- Perform Hands-on Data Management Activities:
- Study Build & Design: Lead eCRF design, generate annotated CRFs, write Completion Instructions, and actively participate in database design and User Acceptance Testing (UAT).
- Data Strategy Documentation: Develop and maintain essential study documents, including the Data Management Plan (DMP), Data Management Project Plan, and Data Quality Review Plan (DQRP).
- Data Cleaning & Harmonisation: Oversee data review, query resolution, and Serious Adverse Event (SAE) reconciliation. You will manage complex non-CRF Third-Party Vendor data streams and resolve medical coding discrepancies.
- Lock & Archive: Flexibly manage post-go-live database modifications, execute soft/hard locks, and coordinate with QA for final archival documentation.
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Qualifications and Experience
- Education: A Bachelor’s or Master’s degree in health/pharmaceutical sciences, physical/biological sciences, or chemistry fields.
- Experience: At least 5 years of experience in pharmaceutical clinical trial data management (or at least 2 years of experience as a CDM II), with a proven track record of meeting high-quality standards and driving customer satisfaction.
- Industry Knowledge: An in-depth understanding of clinical trial data management concepts, dataflows, relevant regulations (ICH-GCP), industry guidance, and data standards.
- Leadership Traits: Demonstrated strong leadership skills in CDM activities and a genuine desire to excel in leading complex data management projects.
Ready to Make Your Next Big Career Move?
If you are a passionate Data Manager looking for project continuity, a "can-do" culture, and a company that truly values your experience, please get in touch.
Apply today by sending your CV or messaging me directly: trish@warmanobrien.com
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