Beschreibung
We are recruiting for a Global Trial Manager (5 years experience) who will contribute to all aspects of global clinical trials to deliver study outcomes within schedule, budget, quality, compliance and performance standards. You will lead matrix teams within specific aspects of global clinical trials and contribute to the operational excellence through process improvement and knowledge sharing.This is an contract position for a minimum of 1 year. Immediate start.
Responsibilities:
- Contributes to all operational trial deliverables, under the oversight of the AssociateGlobal Trial Director, according to timelines, budget, operational procedures, quality , compliance and performance standards.
- Develop study tools, training material, protocol and related documents
- Organization and logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee);
- Timely delivery of trial information and results to the relevant trial repositories and tracking systems (e.g. trial results registries);
- Supporting forecast and management of drug supply and comparator drug products
- Contributing to development of clinical outsourcing specifications to facilitate bid process and selection of CROs; managing interface with CROs in cooperation with outsourcing management and line functions; ensuring vendors meet quality standards; contributing to the development and amendment of vendor contracts;
- Contributing to the development of CRFs, edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and clinical development representative;
- Contributing to the creation and execution of an operational risk management plan, highlighting potential risks and actions;
- Acting as point of contact for all site-related issues and procedural questions;
- Ensuring proper handling of all study close out activities such as site close out, final drug accountability and audit readiness of Trial Master File documentation.
- Supporting the Global Trial Director with the development, management and tracking of the trial level life cycle budget incl forecast, and annual cost targets.
- You will have Financial responsibility: Contribute to trial budget management and review under the oversight of the Associate Global Trial Director.
Requirements:
- Education: Advanced degree or equivalent education/degree in life science/healthcare recommended.
- Languages: Fluent English (oral and written).
- 3-5 years of experience in clinical development with a minimum of 2 years in global clinical research.
- Involvement in cross-functional, multicultural and international clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities.
- Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
- Proven ability to work either independently or in a team setting, to meet goals by managing compliance, budget and timelines.
- Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.