Senior Data Manager, RWE Solutions

About Bionical Emas

Bionical Emas is a global Early Access Programs (EAP) and Clinical Trial Supply (CTS) group bringing life-changing medicines to patients around the world. Their range of services and capabilities benefit many of the world’s leading pharma and biotech companies. At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people. Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success. If you are inspired by changing the lives of patients all over the world, we’d love to hear from you.

About The Role

We are looking for a Senior Data Manager who will be accountable for ensuring the quality and oversight of data management activities for all Real‑World Data projects at Bionical Emas. Responsibilities will focus on partnering with sponsors and internal stakeholders on data management components of study deliverables in a timely manner. This will ensure real‑world data collected across global programs is accurate, standardised, compliant, and audit‑ready, supporting evidence generation aligned to sponsor requirements. The Data Manager will lead the development and oversight of data management processes and SOPs, working cross‑functionally across RWE, EAP Operations, Safety, Medical Affairs, and IT.

What will your job look like?

• 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.

What will you need to succeed?

• 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.

What will you get in return?

• 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.

Does this sound like you? It is time to apply, and we can’t wait to hear from you! Even if you don't meet 100% of the requirements, be confident in yourself and don't hesitate to apply!

Please note: We will be longlisting applications as soon as we receive them, so please apply early to register your interest.

We Are Bionical Emas

We are proud of our people and proud of our achievements. We encourage and hire people with diverse backgrounds, voices, beliefs, and perspectives into our growing global workforce. We do not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, and pregnancy‑related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state or local laws and ordinances. Bionical Emas’ management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Bionical Emas offers equal opportunities and is committed to diversity in its workplace and providing accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with Bionical Emas and need accommodation or special assistance, please let us know by sending an email with your request to the recruitment team at HR@bionicalemas.com.