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At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potentia l of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Project Director – Clinical Operations in Cambridge you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.
As project director acting on behalf of AstraZeneca Innovative Medicines and Early Development (AZ IMED Biotech Unit) – Neuroscience, with specialist focus on clinical operations, you will handle the day-to-day interactions and relationships between the sponsor, delegated vendors and business partners to enable planning, execution, conduct and reporting of high-quality early phase clinical trials consistent with neuroscience project plans and strategic objectives, and in accord ance with FDA, CFR, EMA, and ICH GCPregulations.
Main Duties and Responsibilities
In your role you will actively participate in cross functional project teams representing clinical operations from a tactical and day-to-day execution perspective. You will typically lead approximately two clinical projects simultaneously, in accordance with company objectives and timelines. As part of this you will participate in assessment and selection of Contract Research Organizations (CROs) and where relevant, clinical trial sites, and other vendors and may perform feasibility and qualification visits as needed, solicit and review proposals, review or negotiate budget and Scope of Work.
You will lead the development of the protocol and other study documents in collaboration with the clinical CRO and will have primary responsibility, in collaboration with CRO, for patient or subject sourcing and enrolment to achieve timelines.
During study conduct you will oversee investigating sites' adherence to regulations through review of monitoring reports and will maintain performance and quality metrics for clinical study conduct.
You will be tasked with managing and overseeing the vendor relationship and performance and follow-through, as needed. As part of this you will approve and track vendor invoices and payments to ensure they are in line with contractual agreements. You will support project management functions with budget build and plans for assigned programmes and assist with regulatory (FDA, Competent Authority) and local IRB and Ethics Committee submissions and subsequent responses.
Another part of the role will be to review clinical documents and clinical sections of regulatory documents for accuracy, consistency and quality. Through your work you will contribute to the improvement of processes, systems, tools, procedures relevant to AstraZeneca neuroscience and may be asked to contribute to SOP review, development and adherence.
Finally you will participate in monthly departmental meetings and neuroscience portfolio reviews as required and contribute to due diligence and business partnering activities.
Please note that you will need the ability to travel on an ad hoc basis to meet key responsibilities.
Essential Requirements
Desirable Requirements
To apply please visit https://job-search.astrazeneca.com/job/cambridge/project-director-clinical-operations/7684/7330594
Closing date: 26th March 2018