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
- 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.
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.
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.
Qualifications and Experience
- Education: A Bachelor’s or Master’s degree in health/pharmaceutical sciences, physical/biological sciences, or chemistry fields.
- Experience: At least5 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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Senior Clinical Data Manager employer: Warman O'Brien
Join a leading global biotech organisation that is at the forefront of Oncology innovation, where your expertise as a Senior Medical Science Liaison will be valued and impactful. With a hybrid work model, you will enjoy a flexible work-life balance while being part of a collaborative culture that prioritises employee growth and development through continuous learning opportunities. This role not only offers competitive benefits but also the chance to contribute to groundbreaking advancements in healthcare, making it a truly rewarding career choice.
