Senior Clinical Data Manager I

Everest Clinical Research (“Everest”) is a full‑service contract research organization (CRO) providing a broad range of expertise‑based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve leading companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management centre of excellence.

We are seeking committed, skilled, and customer‑focused individuals to join our winning team as Senior Clinical Data Manager, remotely from a home‑based office anywhere in the UK in accordance with our Work‑from‑Home policy.

• Develop and maintain a Data Management Project Plan (Plan) and document deviations, log and report issues, and follow up on their resolutions.
• Serve as the primary contact for day‑to‑day data management activities and ultimately responsible for all data management deliverables for assigned projects.
• Communicate and discuss data‑management timelines and deliverables; request out‑of‑scope tasks; act as the first‑line contact for technical or procedural issues.
• Plan and implement data‑management timelines and deliverables; provide database and data‑management activity status reports; contribute to overall project planning, progress tracking, and reporting.
• Assist with study‑level resource planning and management, including review of team members’ timesheet reports.
• Perform client‑relationship‑management activities; participate in project bid‑defense meetings when required.
• Perform training on electronic data capture (EDC) systems, data‑flow and quality‑control processes for clinical trial personnel.
• Provide training to new data‑management personnel and perform QC reviews of work by less experienced team members.
• Assist in generating project Work Orders and Amendments.
• Manage data‑flow from and performance of Third‑Party Vendors (Non‑CRF data vendors).
• Participate in project kick‑off meetings, investigator meetings, and regular project‑management team meetings.
• Provide support for client audits and regulatory inspections; follow up on audit findings.
• Create and maintain clinical‑trial Data Management Study Binders.

• Design and review case report forms (CRFs/eCRFs), completion instructions, and annotated forms.
• Design and review clinical trial source‑document templates and completion instructions when required.
• Develop and maintain data validation specifications.
• Develop and maintain Data Management Plans (DMPs); document deviations from the DMP.
• Participate in database design and EDC User Acceptance Testing (UAT).
• Manage database modification processes (post‑go‑live) for protocol amendments or study needs.
• Develop and maintain Data Quality Review Plans (DQRP); coordinate with programmers to complete programming and validation of listings and summary tables as specified in the DQRP.
• Perform third‑party non‑CRF data‑management activities.
• Review data, issue, and resolve queries; assist investigative site personnel with query resolution.
• Perform Serious Adverse Event reconciliation.
• Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures, and medicinal products.
• Cooperate with the Quality Assurance Department on quality‑control audits of assigned databases.
• Perform database soft‑lock and hard‑lock activities.
• Maintain and prepare final archival of data‑management documentation relevant to assigned clinical trials; assist the corporate archivist in assembling and archiving such documents.

• Bachelor’s or Master’s degree in health and/or pharmaceutical sciences, physical/biological sciences, or chemistry.
• At least five years of experience in pharmaceutical clinical‑trial data management or at least two years as a Clinical Data Manager II, with demonstrated knowledge, experience, and ability to meet high‑quality standards and high customer satisfaction.
• In‑depth understanding of clinical‑trial data‑management concepts, processes, and procedures, as well as pharmaceutical clinical‑trial regulations, industry guidance, conventions, and standards.
• Strong leadership in clinical‑data‑management activities and a desire to excel in leading data‑management projects.