Following our continued partnership, Apsida Life Science are in collaboration with a novel Oncology Biotechnology in the Geneva area that are looking to bring on board an experienced and highly motivated Senior Clinical Trial Manager.
Our client hires the best people and provides them with a work environment that places a premium on diversity, integrity, collaboration and personal development. They believe that diverse experiences and perspectives of all the stakeholders in this collaborative project help to drive innovation and exceptional business results.
The successful candidate will manage, drive and coordinate the overall execution of clinical trials, with key stakeholders, in accordance with the approved Clinical Development Plan, from the initiation phase to the final CSR delivery, within the planned time frame and budget and in the sought quality, according to internal SOP, appropriate guidelines (GCP), as well as all regulatory requirements.
Shortened Responsibilities Include (Enquire for a full JD):
- Contribute to all aspects of global clinical trial(s), under the oversight of the Senior Management to deliver study outcomes within schedule, budget, quality/compliance and performance standards.
- Draft clinical trial documents such as Clinical Protocol, CRFs, IB, ICF/PILs, data management and pharmacovigilance agreements, etc..
- Assist in the Feasibility assessments of trials, as well as in the site selection.
- Assist in implementing and coordinating all logistical and operational aspects across all clinical trial functions
- Report study progress and issues/resolution plan during CT Team meeting
- In collaboration with the QA/RA Manager, participate in the creation and maintenance of clinical operations quality documents
- Take responsibility in terms of budget, timeliness and quality of a clinical trial with the senior management.
- Develop clinical outsourcing specifications to facilitate bid process and selection CROs. Lead interface with CROs; ensure vendors meet quality standards; participate in the development/amendment of vendor contracts, and manage vendors from initiation to closing phase.
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Apsida Life Science is a specialist recruitment business based in Central London that is dedicated to delivering the best talent to the Life Science industry. Supporting Pharmaceutical, Biotechnology, Medical Devices and their service providers across Europe and North America, Apsida utilise their extensive and long-standing networks to provide the service our clients and candidates expect. Value for money is something often spoken about but scarcely ever delivered. Apsida’s leadership team is serious about a high-end, professional experience for both candidates and clients alike.