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***Regulatory & Start-Up Specialist, Junior RSU Specialist or Senior RSU Specialist (f/m) - office based in Basel***

Company: IQVIA
Location: Basel
Reference: 1720420
Closing Date: 24 Oct 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

We currently have an exciting job opportunity as (Senior) Regulatory Start-up Specialist (f/m) to work in our Regulatory & Start-up Department in Basle.   PURPOSEPerform tasks associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May participate in feasibility and/or site identification activities. ...

Requirements:

We currently have an exciting job opportunity as (Senior) Regulatory Start-up Specialist (f/m) to work in our Regulatory & Start-up Department in Basle 
 
PURPOSE
Perform tasks associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May participate in feasibility and/or site identification activities.
 
RESPONSIBILITIES

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
  • Review, prepare and negotiate site contracts and budgets with sites.
  • Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
  • Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines.
  • Perform quality control of documents provided by sites.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Effective communication, organizational and planning skills
  • Fluent languages skills in German, French and Italian and good command of English.
  • Ability to work independently and to effectively prioritize tasks
  • Ability to work on multiple projects
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
 
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor’s or higher level Degree or apprenticeship in life science or similar educational background.
  • For a Junior Specialist at least a training in clinical research, for a Specialist at least 3 years of regulatory start-up/submission experience and for a Senior Specialist at least 5 years of working experience. 

Apply for this job: ***Regulatory & Start-Up Specialist, Junior RSU Specialist or Senior RSU Specialist (f/m) - office based in Basel***

Contact Information:

Address:  London Office
210 Pentonville Road London
N1 9JY
England
Tel:  +44 (0) 20 3075 5000
Website:  Visit Our Web Site

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