Atlanta - GA Contract 1 week ago

Job Title: Senior Manager, Country/Cluster CRM

Duration: 9- 12+ months with higher extension possibilities

Job description:

  • To be successful, the ideal candidate should have 5 years of direct trial management experience (pharma or CRO). If consider a study coordinator I’d like to see at least 5 or more given the transition to pharma is different than working in a hospital setting.
  • A successful candidate would need to be able to work independently, be a quick learning, be able to navigate multiple complex reporting systems, able to train-grasp and understand multiple SOPs and the interconnectivity between functions/department, be good at multi-tasking and effective prioritization or work, have a fundamental understanding in soft skills (e.g., conflict management, successful negotiations, communication skills, etc…).
  • I would take on a CRA, but I have also seen that it can be a challenging transition for many given the complexity of the CRM and CTL role.
  • Accountable for day-to-day activities of all aspects for the management of local and/or regional company sponsored studies, including study plans, timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
  • Accountable for the oversight of Investigator Sponsored Studies or Collaborative Research Studies granted by Merck, including the operational assessment of investigator-sponsor, tracking of performance and monitor budgets according to approved plans managing product supply (if applicable), coordinating internal review of final report
  • Manage External providers and/or independent consultants including CROs, Full-Service Provider teams, clinicians, etc.) when required by the project including and not limited to, oversight of the activities and coordination of project specific training, etc.…
  • Develop and monitor study budget and timelines
  • Monitor work to ensure quality
  • Ensures that trial status is accurate and up to date in Clinical Trial Management System
  • Contribute to the planning and set-up of a study and provide planning parameters, support early access programs on the country level of the services you require.
  • Provide product expertise and/or oversight at the country level to external consultants and/or flexible staff working on company sponsored clinical studies
  • May be assigned one or more SME roles within ICSO or CTE functions (eg. Lead at the Country level early access programs in collaboration with the Program Clinical Delivery Lead)

Experience/Education Required:

  • 4-5 years
  • Bachelor of Science
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