Lead Clinical Research Associate 50% (m/f/d)
Manager Cinical Research Coordination
With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.
In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.
- Supports Study Operational Leads in oversight /monitoring clinical deliverables (e.g. site recruitment, site selection, subject/patient recruitment/enrollment, data monitoring, etc.) to ensure that deliverables are documented accordingly and meet quality and regulatory requirements, project timelines, budget.
- Reviews, documents follows up and escalates as needed on Monitoring visits reports across programs
- Under the supervision Clinical Operation Leads supports study teams with clinical and site training plans reviews/inputs. Monitors adherence to the respective plans by timely data entry, query resolution, on and off site data review, to ensure on time quality data deliverables.
- Recognizes potential risks within the monitoring visits reports and operational aspects of the trial; serves as the primary liaison for clinical monitoring, site risks and issues; proactively supports study teams with contingency and mitigation plans. Supports Study operational leads with metrics analysis and reports to keep abreast of performance
- Performs Co monitoring visits, as part of the clinical trial oversight process per Clinical operations oversight plans.
- Collaborates with quality assurance department members to identify study sites requiring corrective and preventative action plans.
- Supports internal audits and health authority inspections as needed. Supports program teams in all Inspection readiness activities.
- Creates, maintains and collaborates on applicable functional documents, plans, templates and tools.
- Supports submission teams with collating document packages for BLAs, responding to clinical queries from Authorities.
- Travels internationally apr.10% of their time
- Fluency in English; German and/or French would be beneficial
- Education – ad minimum Bachelor degree in Life science field
- Previous experience - Minimum 3 years as a Lead CRA
- 3-5 years of experience in Clinical Operations