Clinical Research Manager
- Experience Level
Client: Pharma (Sponsor Dedicated)
- Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
- Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
- Responsible for creating and executing a local risk management plan for assigned studies
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
- Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
- Shares protocol-specific information and best practices across countries\clusters
- 5-6 years of experience in clinical research (minimum of 3 years as a CRA + 1 year as Project Manager)
- Bachelor degree in Science (or comparable)
Please contact Urszula Kaldi on +44 (0) 203 868 1009 / firstname.lastname@example.org for more information
More searches like this
- Clinical Research £40,000 - £59,999 Full Time Permanent jobs in North East England
- Clinical Development £40,000 - £59,999 Full Time Permanent jobs in North East England
- Clinical Project Manager £40,000 - £59,999 Full Time Permanent jobs in North East England
- Clinical Research Associate £40,000 - £59,999 Full Time Permanent jobs in North East England
- Clinical Trials Manager / Administrator £40,000 - £59,999 Full Time Permanent jobs in North East England