I am working on an exciting new Clinical Project Manager (Genotyping) position within a globally leading gene therapy / ophthalmic biotech to support their genotyping efforts outside of the US.
Within this role you will be responsible for the execution of all assigned studies and initiatives that generate genotyping data and identify patients within specific genetic subsets to support interventional trials. This includes execution of genotyping activities, monitoring of deliverables, performing protocol-related site management activities, participating in study planning and set-up activities including vendor management, project management, coordination of study and implementation plans and supporting third party vendor relationships.
The successful candidate will work with fellow operational team members as well as cross functional team members (Medical Affairs, Clinical Development, Commercial and Training) to ensure genotyping goals are met.
- Responsible for the oversight and day-to-day management of global genotyping activities outside of the US
- Ensure that the planning, implementation, coordination and reporting of genotyping initiatives are in line with the corporate objectives
- Work across all interventional trials to ensure that Study team members are able to represent the needs of the Genotyping team and objectives to respective study sites, Investigators and referral networks
- Support and monitor CRO and third-party vendor activities, including Investigator contract/budgets, document management, study set-up, project management
- Prepare and/or review Study Plans
- Monitor progress of studies, identify study-related trends/issues and work with the Clinical Operations/genotyping team to implement corrective actions when necessary
- Work with the genotyping team to develop recruitment strategies
- Contribute to the preparation, design and/or review of essential study documents, ethics and other required local/national submission requirements
- Input into the identification and selection of genotyping investigators as per clinical operations strategy
- Adopt a Risk Management approach to oversight and execution of genotyping initiatives
- Prepare study training materials and present at Internal Workshops, Investigator sites and any other external meetings
- Ensure study certifications, insurance, licenses and registrations are maintained where appropriate
- Minimum 2 years’ experience working as a Clinical Project Manager in Phase I-IV studies within the pharmaceutical industry or a CRO (or potentially an experienced CRA / Associate Project Manager with genotyping experience)
- Extensive experience in direct management of study start up activities
- Independent thinker with ability to anticipate issues and risks and to mitigate accordingly
- Creative thinker who can troubleshoot issues and think outside of the box to achieve Project goals
- Team player who is able to prioritise workload in a fast-paced environment
- ATMP/GMO/Biologics handling
- Ophthalmology experience
- Working within a small to mid-sized Biotech
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