Senior Clinical Data Manager - UK/EU - Remote

London, England, United Kingdom 1 week ago

Overview

Senior Clinical Data Manager position with substantial RAVE experience, focusing on data management study activities, CRO oversight, and delivery timelines.

Responsibilities

• Independently lead data management study activities, CRO oversight, and drive deliverable timelines.
• Strong knowledge of EDC builds utilizing RAVE.
• Represent the data management function on the Clinical Sub-team, ensuring aligned expectations between the CRO and client for all data related deliverables, especially in support of key decision points and regulatory submissions.
• Contribute influential leadership in collaboration with other client stakeholders to ensure milestones and deliverables are met with high quality.
• Partner with stakeholders and CROs to mitigate and resolve risks.
• Provide input to functional governance with client strategic suppliers; resolve issues escalated from vendors and cross-functional teams.
• Participate in preparing the function for submission readiness and may represent the function in formal inspections or audits.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
• Ensure achievement of major data management deliverables and milestones in coordination with Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
• Plan and manage external Data Management budgets and timelines to ensure accuracy, understand variances, and support forecasting improvements.
• Act as a process expert for operational and oversight models.
• Maintain SOPs, process maps, templates and timelines to support operational and oversight models.
• Prepare metrics to support the function’s KPIs.
• Represent the function in external professional initiatives and organizations (e.g., SCDM, CDISC, DIA) to identify industry best practices and increase client visibility.
• Contribute to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines and budget and align with company requirements.
• Ensure compliance with Learning Curricula, corporate and GXP requirements.
• Work cross-functionally to ensure data quality in databases and timely delivery of data management deliverables.
• Performs other duties as assigned.

Qualifications

• Proven recent experience as a Lead Clinical Data Manager with substantial RAVE experience.
• Bachelor's Degree in a science, health-related, or information technology field.
• Minimum 6 years experience in Clinical Data Management with at least 2 years in a Lead role.
• Experience with all phases of development in one or more therapeutic areas preferred.
• Strong knowledge of data management best practices and technologies as applied to clinical trials.
• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management processes.
• Strong knowledge of the broad drug development process with expertise in cross-functional interfaces with the data management function.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing