Job Title: Senior Manager, Country/Cluster CRM
Duration: 9- 12+ months with higher extension possibilities
- 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)
- 4-5 years
- Bachelor of Science