Original Beschreibung
# Global Clinical Master Data Specialist
**Kaiseraugst** | **Full time**
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
### The Position
We collaborate to develop robust manufacturing processes and quality control systems to efficiently transform scientific ideas into products. We reliably deliver quality products to patients enrolled in clinical studies around the world. We excel in our work by creating an engaging and inclusive environment where everyone can bring their skills and talents to developing innovative medicines.
### Who We Are
The **Global Investigational Product Supply (PTDS)** department is responsible for the provision of investigational medicinal products (IMPs) for clinical trials ranging from phase I to phase IV. PTDS handles the planning, packaging, and labeling of IMPs.
The **Global Clinical Master Data Specialist** is tasked with creating, modifying, and maintaining GMP/Quality relevant characteristics of master data objects in CLARA, including material master, classifications and characteristics, production master, production versions, bill of materials, master recipes, resources, work center, business partner data, and more.
Additionally, the **Global Clinical Master Data Specialist** coordinates Engineering Change Management (ECM) workflows. By updating data in the SAP R3P Clinical + APO system, the specialist supports distribution and production planning.
### The Opportunity:
You are the single point of contact for all master data-related functions, issues, and requests, including but not limited to the following tasks:
* Maintain SAP R3P Clinical + APO system master data according to procedures.
* Coordinate ECR workflow activities and interact with requestors (e.g., CH, USA, Pharma Affiliates).
* Coordinate quality reviews and approvals.
* Deliver high service quality of data elements in the SAP R3P Clinical + APO system to customers.
* Coordinate SAP R3P Clinical + APO system accounts and roles in the Corporate Identity Management (CIDM) system.
* Assist with processing Veeva Records.
* Provide customer-oriented services.
* Support team members within the team and other teams.
Additionally:
* Maintain and update all master data-related SOPs, SPTs, SRDs, and other documents.
* Develop lean and efficient processes with high service quality for managing SAP R3P Clinical + APO system data elements regarding Master Data.
* Identify, manage, support, and/or lead continuous improvement projects within the master data area to improve and optimize processes, interfaces, and standards.
### Who You Are:
You bring the following background and qualifications:
* University degree in life sciences, computer science, business administration, or equivalent.
* Experience in project management and in the pharmaceutical industry, preferably in the clinical supply area.
* Sound knowledge of GMP and GCP guidelines (mandatory).
* Minimum of 3 years experience in Master Data Management (mandatory).
* Knowledge in VEEVA, including Deviation, Planned Event, and CAPA Records; experience in documenting deviations, executing root-cause analysis, and risk assessment.
* SAP R3P Clinical + APO system knowledge (preferred).
* Motivation to work according to SAP R3P Clinical + APO system requirements (rules, codes, background jobs, interfaces, etc.).
* High cultural awareness and social competence.
* Customer-focused with the ability to create trustful relationships and excellent problem-solving and analytical skills.
* Well-developed teamwork, collaboration, and negotiation skills; clear and professional communication both verbally and in writing.
* People leadership or cross-functional leadership experience (preferred).
* Ability to work independently with limited supervision, strong planning skills, well-organized, self-motivated, proactive, quick-thinking, and adaptable.
* Ability to set priorities and remain calm and flexible in stressful situations.
* Excellent spoken and written German and English.
**Roche is an Equal Opportunity Employer.**