Senior Data Manager, RWE Solutions

A Career with Purpose

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 worlds 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 wed 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 realworld data collected across global programs is accurate standardised compliant and auditready supporting evidence generation aligned to sponsor requirements. The Data Manager will lead the development and oversight of data management processes and SOPs working crossfunctionally 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

We want you to do your best work! We care about our peoples well-being their personal development and providing a true work-life balance. Our benefits are aligned with our culture and values and are intended to maximize your experience working for us. Here are some of the benefits you can expect from working for Bionical Emas.

• 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 cant wait to hear from you!

Even if you dont meet 100% of the requirements be confident in yourself and dont 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 .

We Are Bionical Emas where each person is unique. We celebrate individuality while encouraging our talents to work as a team. Together we make a difference by powering an inclusive future for all. Be you with us.

Protecting your privacy and the security of your data is a longstanding top priority for us. Please consult our Privacy Notice to know more about how we collect use and transfer the personal data of our candidates. Our Privacy Notice explains what personal information we may process where we may process your personal information our purposes for processing your personal information and the rights you can exercise over Bionical Emas use of your personal information. By applying for the above position you confirm that you have reviewed and agreed to our Data Privacy Notice for Candidates: Privacy Policy - Bionical Emas applicable to your place of residence.

Powering the patient journey