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Job Details

Regulatory & Start Up Specialist 1 (f/m) - office based in Brussels, fixed term 6-12 month

Company: Quintiles
Location: Vilvoorde
Reference: 1624649
Closing Date: 28 Mar 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

PURPOSEPerform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements andcontractual/budgetary guidelines. May participate in feasibility and/or site identification activities. ...

Requirements:

PURPOSE
Perform tasks at country level 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.
  • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
  • Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Review, prepare and negotiate site contracts and budgets with sites.
  • 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.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • 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.
  • Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
  • Perform quality control of documents provided by sites.
  • May have direct contact with sponsors on specific initiatives.
  • May perform Site Selection Visits if a trained monitor.
  • May participate in feasibility and/or site identification activities.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • In-depth knowledge of clinical systems, procedures, and corporate standards
  • Effective communication, organizational, planning and interpersonal skills
  • Ability to work independently and to effectively prioritize tasks
  • Ability to work on multiple projects
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Knowledge of applicable regulatory requirements, SOPs and company?s Corporate Standards
  • Understanding of regulated clinical trial environment and knowledge of drug development process
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
 
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor?s Degree in life sciences or a related field and 1 year?s clinical research or other relevant
experience; or equivalent combination of education, training and experience.
 
 

Apply for this job: Regulatory & Start Up Specialist 1 (f/m) - office based in Brussels, fixed term 6-12 month

Contact Information:

Address:  .
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England
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