Clinical Trial Manager

Hays
Newcastle upon Tyne
4 months ago
Applications closed

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Experienced Clinical Trial Manager for Global Pharma, remote based position, - imm start for 12 month initial contract,

Ideally 4 - 6 years as a Clinical Trial Manager with a Pharma, strong Vendor Management and experience recruiting into challenging studies, EU study management all essential.

Acts as EU Regional Study Manager , as required, under the direction of the Study Leader (SL).

Responsible for the Country/Region study (or studies) and ensures the effective and efficient delivery of country/region operational aspects in accordance with the study milestones, study specific plans, ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements.

Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders for the management of local aspects.

Maintains tracking of country/region study status, provides regular updates and escalates unresolved issues to SL.

Oversees CRO regional budget and reports to SL. If applicable, manages local affiliate study budget.

Provides local expertise to ensure operational feasibility and delivery of the overall study

Provides operational input into the development and tracking of study team goals.

Provides operational input and insight from a country/regional perspective into all study related documentation (including protocol and informed consent form) and processes.

Provides input from a country/regional perspective into study level patient recruitment plan and retention strategies created by CRO and the study team based on site feasibility data.

Builds effective, high performing LSTs through influence, integration, motivation and optimization of CRO performance and communication with the SL.

Oversees CRO study conduct in the responsible countries/region(s) in line with overall study team plan

Participate in the review of any management plan by the CRO (Study management plan, monitoring plan, recruitment plan, quality management plan, recruitment plan, safety management plan etc)

Ensures study adherence to ICH/GCP, SOPs and local regulations

Oversees CRO to ensure protocol adherence and consistency of study processes and procedures across all investigational sites in his/her responsible region.

Develops and executes appropriate site and CRO/vendor audit and quality plans in collaboration with Audit Function.

Early Phase experience as a CTM essential


Out of scope, and remote, immediate start.

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