Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a
Data Quality Lead
Background:
The Data Manager leads the design, implementation, and oversight of data management activities across one or more studies. This includes database setup, data cleaning, query resolution, and vendor oversight, with a strong emphasis on regulatory compliance, efficiency, and data readiness for analysis. The role requires both technical acumen and collaborative leadership to anticipate challenges, drive process improvements, and enable high-quality data delivery across the clinical portfolio.
You have proven capabilities in driving external vendors and partners in delivering high quality databases. You have strong programming skills which enables you to contribute effectively to EDC system development and maintenance in collaboration with IT.
Tasks & Responsibilities:
- Operate as the core representative for Clinical Data Management on the study team and to be accountable for collection
- Review and management of data and ensure deliverables are met
- Leads the CDM study team and maintains oversight of all build, conduct and close activities for one or more studies, ensuring fit for purpose quality
- Implements study conventions, processes, knowledge sharing and best practices on assigned study(s)
- Actively contribute to EDC system programming and maintenance. BA/BS degree or equivalent and moderate industry-related experience
- Practical and theoretical expertise within his or her sub function
- Programming and system development expertise required. In-depth understanding of the business of his or her sub function and the wider CDM organization
Must Haves:
- A BA/BS degree (or equivalent) coupled with moderate industry experience (3-5years) in a clinical research environment
- In-depth understanding of CDM business processes and how they align with global regulatory requirements (GCDMP, ICH-GCP, etc.)
- Expertise in ensuring data is "analysis-ready," requiring a theoretical and practical grasp of data flow from collection to submission
- Proficiency in programming (e.g., SQL, SAS, or Python) to collaborate effectively with IT and drive system enhancements
- Experience acting as the Primary Point of Contact (POC) & Leadership for CDM in cross-functional settings
- Fluency in English written and verbal communication
- Excellent presentation and communication skills are required
Nice to Have:
- Vendor oversight and management experience
What you will be offered:
- An opportunity to work in one of the world's most important pharmaceutical companies
- Modern campus with plenty of green spaces and meeting areas
- Central location in Basel
- Varied job profile
- Further training opportunities through temptraining
- Working in a dynamic and motivated team
If you are interested please send your application documents addressed to Ms Diana Afonso.
Basel-Stadt Aargau Solothurn Pharma Chemie Quality SQL SAS Python CDM GCDMP