Clinical Scientist - PHARMA (ro-975)

Status: 
paused
Location: 
4070 Basel
Start Date: 
2017-07-31
End Date: 
2018-07-30
Deadline: 
2017-07-11 14:30
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
2.088
Assignment: 

background

Provides early clinical development study leadership in overall study planning, preparation, management, evaluation and documentation, leads activities and is accountable for key deliverables

Primary Responsibilities and Accountabilities

  • Lead development of study protocols and related documents, e.g. case report form, informed consent form, clinical trials postings and source document verification plan
  • Key-contributor to responses to regulatory agencies/institutional review boards (IRB)
  • Participate in study management: Clinical scientists with sufficient experience may lead the clinical team meetings
  • Represent Translational medicine on study management teams (SMTs)
  • Co-lead the ongoing review of study data with study physician
  • Provide support for the protocol-related training of clinical operation colleagues and study site staff
  • Serve as a key internal contact for study related clinical and scientific issues
  • Provide input for final study report and annual report documentation
  • Support safety representatives in the serious adverse events reporting process
  • Ensure GCP compliance in assigned studies
  • Assist in the preparation of the clinical development plan for relevant investigational agent
  • Participate in review of regulatory documents, e.g., clinical study reports, investigator’s brochure, safety reports and submissions to health authorities
  • Assist in preparing materials for internal and external presentations such as advisory board meetings
  • Present study data summaries at team meetings and/or investigator meetings
  • Participate in the development of scientific publications, e.g., abstract submissions to scientific congresses

 

Requirements: 

 

  • PhD-/MD-/PharmD-level (or equivalent relevant experience)
  • Five or more years of experience in clinical research  
  • Ability to acquire knowledge in different diseases and therapeutic areas
  • Leadership skills, including motivating, delegating, coaching, and mentoring
  • Personnel managerial experience
  • Demonstrates initiative and independent thinking in advancing projects
  • Works well within a team
  • Excellent communication skills
  • Fluency in English
  • Ability to travel nationally, regionally and/or internationally
Prefered Interview Dates (YYYY-MM-DD): 
2017-07-13