Clinical Trials

As part of the CO Expert Chapter the Clinical Trial Expert is accountable for a range of areas driving all phases in the execution of trial(s). The role will require enterprise wide interconnectivity and networking and monitoring of the internal and external environment S/he is responsible for the delivery of operational portfolio activities in support of the Programme Management Chapter within timelines, budget, quality while contributing towards the CO North Star of improving productivity and approaching study delivery from a patient centric mindset. The Postholder will be accountable for delivering strategic components within their area of expertise that improve productivity metrics of CO. Members of the Expert Chapter can have a wide variety of contributions which impact the delivery of pRED portfolio

WHAT YOU WILL DO:

• Ensures the Clinical Operations organisation achieves and maintains a sustainable high level of portfolio delivery performance by, implementing and maintaining solutions that deliver on the CO North Star.
• With a strong background in trial execution contribute to specific study strategies
• Establishes, and maintains optimal relationships with key internal partners, stakeholder groups, and external partners.
• Clinical Trial Experts support the quality of CTs, by participating in audits and inspection readiness though the study lifecycle while contributing to CAPAs as required.
• Leadership role in the implementation of systems maintenance, tools and reports required across the clinical trial life cycle (eCOA, IxRS etc). Coordinating imaging and rater components of study startup, including input into requests for proposal, authoring of documents and potentially site personnel training.
• Contribute to the development and maintenance of relevant study oversight documentations/charters (i.e. trial risk management plan, communication plan, monitoring plan, data cleaning plan, etc.).
• Track clinical study progress and address issues that may come up in close collaboration with study teams, affiliates, sites, and CROs as appropriate. Collaborate with stakeholders in generating relevant reports and KPIs to monitor trial progress.