Ref #: 26486

Employment type: Permanent - Full-Time

Location: United Kingdom

Posted: 15-Feb-2021

Description

Responsibilities:

• Complies with all the training
• Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of pre-trial assessment visits and appropriate follow-up of pre-trial visit report and country feasibility report.
• Collaborates with central study team for final selection of sites to participate in trial.
• Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations.
• Recruitment planning, contingency and risk management, and budget forecasting.
• Act as primary company contact for assigned trial at the country level, may attend/participate in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.
• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. When necessary initiates corrective and preventive actions (CAPA)when the trial deviates from plans and communicates study progress and issues to study management teams.
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study supply.
• Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating CRA training, when needed (i.e.implementation of study amendment-and changes in study related processes).



Education and Experience required:
• BA/BS degree.
• Degree in a health or science related field.
• Minimum of 1 year of UK local trial management experience, managing CRAs in the delivery of the trials within a CRO or Pharma setting.
• MUST have UK Ethics and HRA submissions experience
• Budget experience/oversight of Budget
• Specific therapeutic area experience in Immunology OR Infectious Diseases
• Strong working knowledge of ICH-GCP
• Strong IT skills in appropriate software and company systems.
• Willingness to travel with occasional overnight stay away from home according to business needs.
• Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.

Please note you must already be located in UK and have the right to work without the need of Sponsorship.

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