Senior Clinical Research Associate / Study Manager I

Switzerland, Zug, Rotkreuz RDI

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• Job facts

The European RMS Clinical Operation group is part of RMS Clinical Operations Biometrics (COBM) team and is responsible for conducting external registrational and non-registrational studies for RMS products from early development through post-launch phases. We are collaborating across multiple sites in Europe and US to conduct external studies according to applicable international and local regulations.

We are looking for a Senior CRA or Study Manager I who will be responsible for conducting and managing clinical study activities to verify and validate new, instrument platforms, assays, clinical software and biomarkers developed by RMS.

The advertised position offers:

• Responsible for the overall conduct and management of clinical studies


• Works independently to complete CRA functions associated with study planning, implementation, monitoring and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).


• Travels to field sites to independently monitor studies and provide technical assistance, as necessary.


• Ensures collection and maintenance of study documentation (e.g. monitoring plan and reports), legal and regulatory documentation, as applicable.


• Ensures that adverse events, adverse device effects, and incidents occurring during the study are correctly recorded and forwarded within Roche


• Ensures site compliance with regulations, applicable SOPs, GCP, local regulations and study protocol.


• Acts as first point of contact and provides technical assistance to the sites, as necessary.


• Verifies that source data/documents and other trial documents (e.g. Case report forms, Informed Consents) are accurate, complete and maintained in accordance with data protection regulations


• Interacts with Roche teams at multiple locations (e.g. Rotkreuz, Mannheim, Pleasanton, Tucson), international investigators, key opinion leaders and customers.

To be successful in this role (you have to):

Bachelor degree in scientific discipline or related field required, or equivalent combination of education and work experience.

• 5+ years of experience in clinical study coordination, clinical site monitoring or clinical study management is required, 7+ preferred.


• Prior experience with current Good Clinical Practices (cGCP), IVD-D and Code of Federal Regulations (CFR) is preferred.


• A background in biomedical/healthcare services with laboratory experience preferred.


• Excellent writing and verbal communication skills.


• Excellent English speaking and writing skills, German is a plus


• Well organized and detail oriented


• Impeccable record keeping and filing skills


• Excellent time management skills


• Ability to work effectively in a cross-functional team at multiple locations in Europe and US


• Work independently on assigned tasks

Ability to travel (international and domestic) approximately 30%

Roche is an equal opportunity employer.

Research & Development, Research & Development > Clinical Operations

• Who we areRoche Diagnostics International Ltd in Rotkreuz is one of the world's leading providers of diagnostic system solutions for clinics, laboratories and doctors' offices. The company employs over 2200 people in Rotkreuz and is one of Roche Diagnostics' main sites. Read more.
  
  Roche is an equal opportunity employer.


• Job facts
  
  
  
  • Location Switzerland, Zug, Rotkreuz RDI
  
  
  • Function Research & Development
  
  
  • Subfunction Clinical Operations
  
  
  • Schedule Full time
  
  
  • Job level
  
  
  • Job type Regular
  
  
  • Division Diagnostics
  
  
  • Posted since 2018/09/06
  
  
  • Job-ID 201808-117002
  
  


• Get in touchMr. Malek Al-Odeh


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