Clinical Scientist Specialist, Rare Diseases (Temporary, 1 year)

     
Employer
Published
WorkplaceBasel, North West Switzerland, Switzerland
Category
Position

Description

Clinical Scientist Specialist, Rare Diseases (Temporary, 1 year)

Switzerland, Basel-Town, Basel

This position is within the Rare Diseases team, part of the Pharma Research and Early Development (pRED) organization. The position supports the overall planning, evaluation and documentation for assigned global Phases I-II studies in close cooperation with Clinical Scientists (CS) and Translational Medicine Leader (TML)

  • Contribute to key study documents (protocols, ICFs, clinical study reports) and drive development of relevant data capture tools and perform periodic data review and data cleaning
  • Responsible for the preparation of the clinical science components of the study specific manuals
  • Support in the evaluation, interpretation and synthetic presentation of various scientific/ clinical data. Help in providing response to regulatory agency questions
  • Participate in study management as clinical science representative to ensure trial deliverables are met according to timelines, budget, quality standards and operational procedures, within a global multidisciplinary cross-functional Study Management Team (SMT)
  • Accompany operations personnel on site visits and provide training and science input to operation colleagues and study site staff, as agreed with clinical operations
  • Monitors study progress on a regular basis to identify any problems or issues that could affect the results or completion of the study; investigates and employs problem solving strategies.
  • Provide help in literature search, creation of dossiers on scientific and medical topics
  • Assists in the preparation of scientific abstracts, posters, and publications arising from studies in conjunction with clinical investigators.

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

We are looking for a professional with advanced scientific degree (e.g. PhD, MS) in a relevant scientific field (e.g. neuroscience, pharmacology, molecular biology, genetics) and +1years of experience in clinical trials (early phase preferable), preferably in a global position. You will bring:

  • Experience in rare diseases / orphan drug development would be a plus
  • Able to collaborate and work in a matrix environment and interact with a variety of individuals outside (investigators, partners) and inside the company (e.g. regulatory affairs, biostatistics, clinical pharmacology, CMC, project management)
  • Comfortable/experienced with data cleaning, data capture, monitoring and reporting tools
  • Strong communication and time-management skills to drive quality results
  • Familiar with ICH-GCP regulation and regulatory guidance documents about clinical trials
  • Fluent in English

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche’s largest sites. Read more .

Roche is an equal opportunity employer.

  • Location Switzerland, Basel-Town, Basel
  • Function Research
  • Subfunction Early Development/ Translational Medicin
  • Schedule Full-time
  • Job level Individual Contributor
  • Job type Temporary Employee
  • Division Roche Pharmaceuticals
  • Posted since 2018/02/13
  • Posted until 2018/03/15
  • Job-ID 3099179004


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