Clinical Trials Manager
- Job type: Permanent
- Salary: competitive
- Location: Dublin
- Reference: RE-32496740
This role will be responsible for full trial execution from protocol generation and input to clinical trial report/manuscript writing and publications, including management of third party vendors. The Clinical Trial Manager will be also be accountable for ongoing and effective collaboration with senior management and co-workers on clinical trial progress.
* Significant Clinical Operations experience with managerial experience in planning, executing, and reporting clinical studies in a pharmaceutical company or contract research organisation.
* Proven ability to work independently.
* Good project management and communication skills *
* Ability to resolve issues with minimal supervision and work well under tight timelines to deliver results
* Thorough knowledge of Good Clinical Practice, clinical trial design, data management operations, general understanding of regulatory environment, and global clinical drug development process.
* Effective site management and organisational skills, with ability to establish and maintain effective working relationships with third party vendors, senior management and co-workers
* Must be flexible and able to amend work plans/timelines at short notice to meet company objects
* Willingness to travel internationally up to 40%
* At least 5 years' experience in a clinical role within a pharmaceutical company or senior role in a contract research organisation.
* Experience in completing the life cycle of Phase2b or Phase3 clinical trials
* Experience with maintaining and updating or contributing to Clinical Department Quality System.
* Understanding of pre and post -marketing pharmacoviligence requirements
* Knowledge of clinical trial services (e.g. eCRF, IxRS, PRO and central laboratories)
* Strong software and computer skills, including MS office applications
* Understanding of financial budgeting and forecasting
* Knowledge of IMP supply logistics and CMO activities.
* Understanding of general GMP activities
This is a permanent role with interviews taking place over the next few weeks. An excellant salary and benefis package on offer with a lovely working environment.
This is a fantastic opportunity and a really exciting role. If you are considered please apply now with your current CV or contact me for more information.