Parexel

Country Study Operations Manager – FSP

Parexel

full-time

Posted on:

Origin:  • 🇭🇺 Hungary

Visit company website
✨ AI Apply
Manual Apply

Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
  • Serves as leader of the local study team on one or more studies
  • Oversees the pCRO/CTM/SCP for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (timelines, budget, risk, and quality plans)
  • May manage the study start up process in countries assigned and/or oversee the pCRO responsible for these activities as applicable
  • Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs)
  • Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM during planning
  • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required
  • Accountable for resolution of site activation escalations to study teams including offering options for mitigation
  • May be responsible for regional, country and study level implementation of startup and site activation plans, recruitment strategy, and study level plans
  • Supports development of TMF set up and ensuring TMF completeness; maintains oversight of ISF reconciliation
  • Supports identification, contract development and management of local vendors or facilities as per protocol
  • Provides Investigator Meeting (IM) support and management
  • Provides country level documents to TMF and maintains oversight of ISF reconciliation and completeness actions
  • Supports submissions to ECs, Regulatory Authorities (RAs), and other relevant bodies within required timelines
  • Ensures ICH GCP standards and Parexel SOPs compliance; manages quality events and data issues
  • Drives data cleaning deliverables for pCRO and sites; coordinates site recruitment planning for country/site targets
  • Maintains knowledge of Parexel processes and global/local regulatory requirements
  • Supports implementation of client’s site technology experience systems

Requirements

  • Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
  • Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
  • Demonstrated clinical research experience and/or study management/startup project manager experience
  • Demonstrated experience in managing country level operational activities and/or vendors
  • Knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility
  • Demonstrated experience in managing country level operational activities and/or vendors
  • Fluency in written and spoken English
  • Ability to travel as required
  • Experience in study management/startup project management environment