Senior Data Manager, RWE Solutions

Bionical Emas

Senior Data Manager ensuring quality and oversight of Real World Data projects at Bionical Emas. Leading data management activities and compliance for global programs.

Posted 4/30/2026full-timeRemote • 🇬🇧 United KingdomSeniorWebsite

Tech Stack

Tools & technologies

AWSAzureCloud

About the role

Key responsibilities & impact

Lead end-to-end management, governance, and quality of real world data (RWD) initiatives, serving as the primary point of contact for all Sponsor deliverables, escalations, and timelines
Design and implement robust data governance and quality frameworks tailored to Early Access Programs and broader observational research, including risk identification and mitigation
Ensure consistent mapping, standardisation, and interpretation of real world data elements across geographies, programs, and data sources, including reconciliation of clinical, site-reported, and safety datasets
Develop and maintain Standard Operating Procedures (SOPs), Work Instructions, and data management documentation covering data design, processing, quality control, coding, transfers, and archiving
Build and manage studies within the EDC system, overseeing study specification documents including Data Management Plans, Data Validation Plans, and eCRF Completion Guidelines across all study builds and revisions
Perform ongoing data quality checks, discrepancy management, and issue resolution, while proactively ensuring all program milestones such as data cuts, DBLs, and TFLs are met on time
Ensure full compliance with applicable global privacy and regulatory requirements including GDPR and HIPAA, maintaining audit-ready documentation and version control across all programs
Manage medical coding activities using standard terminologies including MedDRA, WHO Drug, SNOMED, ICD-10, and ATC, and deliver well-documented datasets to support HEOR analyses and regulatory evidence packages
Collaborate cross-functionally with Regulatory, Medical, Compliance, and external vendor teams, supporting sponsor audits, inspections, and RFP processes including bid defence meetings
Drive continuous improvement through automation, standardisation, and tool optimisation, contributing to the evolution of organisational standards for real world evidence in early and expanded access settings

Requirements

What you’ll need

Background in pharma, biotech, CRO, or an RWE-focused organisation
Proven experience in real world data management, observational or non-interventional research, including hands-on knowledge of clinical or RWE data environments
Practical experience with medical coding standards (MedDRA, WHO Drug, SNOMED, ICD-10) and strong working knowledge of GDPR, HIPAA, and global data privacy frameworks
Demonstrated ability to develop, maintain, and govern SOPs and controlled documentation
Familiarity with Early Access or Compassionate Use programs, HEOR, epidemiology, or pharmacovigilance would be advantageous
Experience with cloud data platforms (Azure, AWS, Databricks, Snowflake), eCRF systems (Zelta, Medidata Rave, Castor), or OMOP/OHDSI frameworks

Benefits

Comp & perks

25 days of vacation
Vacation days purchasing scheme
1 extra vacation day per each 3 years of service
Discretionary Annual Bonus
Sabbatical of 3 to 6 months (after 2 years of service)
Free food and beverages at all offices
Life Insurance
Health Insurance and Employee Assistance Programme
Employee Support Networks – help us continue to build on our inclusive culture
Flexible and hybrid work

ATS Keywords

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Hard Skills & Tools

data governancedata quality frameworksdata managementmedical codingdata quality checksrisk identificationdata reconciliationdata processingdata validationdata archiving

Soft Skills

leadershipcollaborationproblem-solvingcommunicationorganizational skillscontinuous improvementcross-functional teamworkproject managementattention to detailadaptability