Study Start Up Specialist/Country Study Specialist (12 months)

Switzerland, Basel-Country, Reinach

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• Job facts

Study Start Up Specialist/Country Study Specialist (12 months)

Roche Pharma Switzerland is an important partner in the Swiss healthcare system and covers marketing & sales, medical affairs, regulatory affairs, market access, reimbursement and quality assurance for Roche medicines in Switzerland. Roche Pharmaceuticals Switzerland has been based in Reinach, BL since 1992 and has around 170 employees.  

We are now looking for a new Study Start-Up Specialist/Country Study specialist that will support us during the next 12 months.

Responsibilities:

• Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.


• Executes all start-up activities prior to site activation on assigned studies, according to Roche standards and aligned with study/project requirements and timelines.


• Prepares country level Informed Consent Form (ICF) and obtains ethics committees’ and local regulatory authorities’ approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country


• Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.


• Partners with Clinical Study Managers (CSM5) and Clinical Study Specialists (CSSs) to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.


• Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department, as required.


• Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies! laws, via innovative approaches


• Submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SIJSAR5), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs).


• In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.


• Responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensures compliance with Fair Market Value (FMV) in the country.

Requirements:

• University Degree or equivalent, preferably in a medical/science-related field.


• Demonstrated knowledge and understanding of clinical trials and experience in managing projects.


• Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials in the relevant country


• Fluent in German and English, French would be an advantage

For further information, please reach out to Ellen van Vijnckt (+41 61 715 43 74) or Christine Müller, HR Partner (+41 61 715 43 96). Please apply directly online in Workday.

• Who we areRoche Pharma (Switzerland) Ltd is based in Reinach and employs about 150 people in marketing and sales, clinical research, regulatory approvals, market access, scientific documentation and provision of medical advice. Read more.
  
  Roche is an equal opportunity employer.


• Job facts
  
  
  
  • Location Switzerland, Basel-Country, Reinach
  
  
  • Function Research & Development
  
  
  • Subfunction Clinical Operations
  
  
  • Schedule Full time
  
  
  • Job level Individual contributor
  
  
  • Job type Temporary (Fixed Term)
  
  
  • Division Roche Pharmaceuticals
  
  
  • Posted since 2019/01/18
  
  
  • Posted until 2019/02/19
  
  
  • Job-ID 201901-101612
  
  


• Get in touchMrs. Christine Müller


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