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Clinical Study Data Excellence Lead (all genders)

Merck
Pologne  Varsovie, Pologne
Médecine/Santé, Anglais
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Description du poste:

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

YOUR ROLE:

As our Clinical Study Data Excellence Lead, you'll own end-to-end Clinical Study Data Management across R&D, coordinating work by CROs, FSPs, and vendors. This Director-level role defines and continuously improves process standards, controls, KPIs, quality documents, and training to ensure inspection-ready, GxP-compliant processes aligned with ICH GCP (E6(R3)). You'll drive automation and digital enablement to boost quality, efficiency, and scalability, and serve as the primary process expert during audits and inspections. You'll read the room, facilitate conversations with higher management, and act as a proactive project sponsor-proposing actionable strategies to address the problem statements. Partner with R&D, IT, vendors, BPOs, and senior leaders to embed a culture of process excellence, innovation, and risk-based decision-making.

WHO YOU ARE:

* 15+ years in clinical development operations, clinical data management, or clinical quality within pharma, biotech, or CRO settings.

* Experienced as an Operational Excellence Lead, Business Process Owner, or Quality/Compliance Lead with SOP authorship, process governance, audits/inspections, and continuous improvement.

* Possess deep knowledge of ICH GCP (E6(R3)), regulatory requirements, and trial frameworks (CDISC, TransCelerate).

* Expert in process measurement, KPI dashboards, performance reporting, CAPA governance, and GxP compliance.

* Have strong grasp of clinical data management systems (EDC, data review benches, central data monitoring, digital workflow tools).

* You tailor messages for contributors, stakeholders, and leaders, able to communicate across all levels.

* Influence without formal authority; build consensus and align with vendors and senior teams.

* Future-focused; you identify automation and digital opportunities to boost quality and scalability.

YOUR MAIN BENEFITS:

* Health and well-being: Get access to private medical care, life insurance, and sports card, receive prepaid lunch card

* Work-Life balance: Enjoy additional paid days off, flexible working hours.

* Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities

* Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection.

Information on how we process your personal data for recruitment purposes, you can find on the registration form in our Recruitment Portal.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Job Requisition ID: 300846

Location: Warszawa

Career Level: E - Professional (10+ years)

Working time model: Full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information

Origine: Site web de l'entreprise
Publié: 07 Jui 2026  (vérifié le 08 Jui 2026)
Type de poste: Emploi
Secteur: Santé
Langues: Anglais
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