Job Overview :
Covance UK is currently recruiting for a Local Clinical Study Manager to join a large client dedicated Team to work mainly on cutting edge Oncology trials but possibly also Vaccines, Hepatitis and HIV studies.
This pivitol, client facing position will involve driving recruitment targets and functionally leading a team of CRAs across the UK.
Other responsibilities include :
Main Point of Contact for assigned protocols and link between Country Operations and clinical trial team.
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, 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.
Performs Quality control visits as required
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
Ensures compliance with CTMS, eTMF and other key systems in assigned studies
Escalates as needed different challenges and issues to TA Head / CRD / CQM and or CTT.
Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
Country POC for programmatically outsourced trials for assigned protocols.
Serves local business needs as applicable in his / her country(If delegated can sign contracts and manage budgets)
As a customer-facing role, this position will build business relationships and represent MSD with investigators
Other Information :
This role is a full time & permanent position to be employed through Covance. Candidates can be based anywher in the UK.
For more information please contact Andy Smith at andy.smith covance.com or call +44 (0)1635 253 724
Key words :
Clinical Research Manager, CTL, UK, England, Lead CRA, GCP, Oncology, Clinical Project Manager, Field Based, CRO, Pharmaceutical, CTL, Clinical Team Leader, Local Study Manager
Education / Qualifications :
Bachelor degree in Science (or comparable)
Advanced degree, (e.g., Master degree, MD, PhD
Experience Requirements :
5-6 years of experience in clinical research of which 3 as CRA