START-UP OFFICER

Pharma Point, on behalf of a growing pharmaceutical Contract Research Organization (CRO) with more than 20 years of experience in Life Science field, is looking for a 
START-UP OFFICER


MAIN RESPONSIBILITIES & ACTIVTIES

The Start-up Officer, reporting to the Clinical Research Regulatory Coordinator, will be involved in the performance of the following activities:
  • Participating in feasibility process and/or site identification activities
  • Keeping contact with the ECs and hospital administration during the start-up phase
  • Collecting information from site to initiate the submission process and contract negotiation
  • Working with the study Project Manager and the sponsor to collect all the requested documents
  • Assembling the regulatory and EC submission packages
  • Following up with EC after the submission and ensuring that any possible request or question from the EC is promptly managed and answered
  • Collecting the EC or regulatory approvals and ensuring they are appropriately filled, both in paper and electronic format
  • Ensuring that the regulatory approvals are circulated to the sponsor and to the other local sites
  • Working with CLR Regulatory Coordinator on site contract negotiation procedures
  • Following the start-up study tracking and internal reporting to the PM and the CLR Regulatory Coordinator
  • Escalating any severe QA issues or deviations to the CLR Regulatory Coordinator and/or the QA
  • Filling the study documentation generated/collected during the start-up phase
  • Informing study team members of completion of regulatory and contractual documents for individual sites to allow site initiation
  • Contributing to amendments or other submissions and to the development of standard operating policies and procedures for site start-up activities

PROFILE
  • Previous experience of 5 years minimum in the role
  • Proficiency knowledge of written and spoken English
  • Proven organizational and administrative skills
  • Excellent organization and time management skills, attention to detail and ability to multitask
  • Team oriented and flexible
  • Domicile: Pavia/Milano/Lodi
Business unit
Clinical Operations
Sedi
Italia/Lombardia/Lodi; Italia/Lombardia/Milano; Italia/Lombardia/Pavia

CONTATTI

Pharma Point Srl - Foro Buonaparte, 48 - 20121 Milano, Italia

Email: info@pharmapoint.it - Tel. +39 02-89013167

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