Senior/Global Trial Manager - Outsourced - UK
One of the largest CROS in the global market is currently recruiting a Senior/Global Trial Manager - Outsourced to their UK team on a home-based capacity. This contract research organisation (CRO) is renowned for their work in technological advances and access to real-world data. This is an exciting opportunity to become embedded in the wider clinical operations team and work on ground-breaking new medicine development.
The Trial Manager will contribute to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance, and performance standards. They will also lead specific aspects of global clinical trial(s) and act as a core member of the Clinical Trial Team.
- Contributing to all operational trial deliverables, under the oversight of the (Associate) Global Trial Director, according to timelines, budget, operational procedures, quality/compliance, and performance standards. Assigned responsibilities can include but are not limited to:
- Developing specific sections of the protocol and related documents.
- Developing of study tools, guidelines, and training materials.
- Organising the logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee).
- Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries).
- Supporting forecast and management of drug supply and comparator drug products in collaboration with internal stakeholders.
- Contributing to the development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs).
- Managing the interface with CROs in cooperation with outsourcing management and line functions.
- Ensuring vendors meet quality standards.
- Contributing to the development/amendment of vendor contracts.
- Contributing to the development of Case Report Forms (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.
- Implementing issue resolution plans.
- Acting as point of contact for all site-related issues and procedural questions.
- Managing interactions with relevant line functions including data management, drug supply management, and clinical development.
- Ensuring proper handling of all study close out activities, including but not limited to, 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, including forecast, and annual cost targets.
- Acting as a core member of the global cross-functional Clinical Trial Team (CTT).
- Participating and reporting study progress and issues/resolution plan at the CTT meeting.
- Writing CTT meeting minutes.
- Organising and chairing trial sub teams within the scope of his/her delegated responsibilities. Extended member of the Global Clinical Team (GCT).
- Defining the Data Review Plan; participating in data review as specified in the Data Review Plan.
- Contributing to talent development through active participation in onboarding and training activities; may participate in GDO Trial Management initiatives and working groups.
- Being responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and franchise, including sharing lessons learned.
Skills and Requirements:
- Advanced degree or equivalent education/degree in life science/healthcare recommended.
- 2-4 years of experience in clinical development.
- Involvement in cross-functional, multicultural, and international clinical trials.
- Demonstrable capabilities in supporting operational aspects of clinical trial related activities.
- Proven networking skills and ability to share knowledge and experience amongst colleagues.
- Knowledge of Good Clinical Practice.
- Comprehensive knowledge of clinical trial design.
- An understanding of the overall drug development process.
- Basic knowledge of appropriate therapeutic area.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Theodora Savlovschi - Wicks at +44 203 752 0314 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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