Senior Data Manager, RWE Solutions

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🕒 April 30

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Bionical Emas

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1998

💊 Pharmaceuticals

🤝 B2B

Pharmaceuticals • B2B

Bionical Emas is a B2B life sciences services company that provides clinical development and pharmaceutical support, including clinical trial supply, regulatory affairs, pharmacovigilance, medical affairs, quality assurance, and distribution/logistics. The company appears to support pharmaceutical and biotech organizations with trial management, patient access, and related operational services, and recruits professionals across these functions.

📋 Description

• 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

• 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

• 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