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).
- Accountable for project management of the allocated 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.
- Responsible for performance for allocated 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.
- Evaluates and reviews monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Carries out Quality control visits as required
- Generating high performance by leading the teams: 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 ensuring compliance with CTMS, eTMF and other key systems in assigned studies
- Accountable for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
- Serves local business needs as applicable in his/her country(If delegated can sign contracts and manage budgets)
- 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.
- 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 Sophiya Pun on +44 (0) 203 928 8387 / email@example.com for more information
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