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Regulatory and Start-Up Specialist 1 (f/m) - office based in Espoo, Fi - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

  • Województwozagranica
  • Miejscowośćinne
  • AdresFinland,
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Regulatory and Start-Up Specialist 1 (f/m) - office based in Espoo, Fi

Nr ref.: /JOBS.pl

  • 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 andcontractual/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
    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
    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.


    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 relevantexperience; or equivalent combination of education, training and experience.


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