Opening For Associate Director Clinical Operations : Cambridge

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Amar Annamalai
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Opening For Associate Director Clinical Operations : Cambridge

The Associate Director (AD), Clinical Operations represents clinical operations on the Product Development Team (PDT) and/or Global Product Team (GPT) and is responsible for overseeing all operational aspects of a single or multiple development programs. This role provides strategic operational input and design into the Clinical Development Plan. The strategic overview is the critical element of this role.
 
This function leads the operational planning and oversees delivery of clinical studies to agreed budget, time and quality. As well as managing multiple internal and external stakeholders including Key Opinion Leaders (KoLs) and vendors .The focus is across the program level collaborating with the Clinical Development Organization, PDT/GPT counterparts and all other functions that are key to the development of a compound to facilitate good decision-making throughout the development life cycle.
 
Major Duties and Responsibilities (including supervising others)
 
• Design the clinical operational strategy for the Clinical Development Plan (CDP) with the Medical Director.
• Provide expert clinical operational input into: integrated Product Development Plan (iPDP), Clinical Development Plan (CDP), Protocol Concept Sheet (PCS), Clinical Study Protocol (CSP), and Clinical Study Report (CSR), to ensure seamless delivery of studies through effective collaboration
• Deliver differentiated and robust operational design options for review at Investment Decision Governance interactions (ie. PDT, iMED, Clinical Functional Review, ESPC and others as appropriate)
• Oversee the operational delivery of the Clinical Study Program(s) from CD Nomination to final CSR and through to study closed and archived to agreed budget, time and quality and aligned with Key Performance Indicators (KPIs)
• Plan and lead interactions, including issue escalation and resolution between Clinical Operations, Clinical Trial Teams (CTTs), CST and the PDT/GPT 
• Accountable for driving accurate clinical resource forecasting.
• Collaborate closely with Resource Performance Management to deliver ongoing program feasibility assessment
• Develop and manage clinical program risk and opportunity mitigation plans to ensure delivery to timelines, budget and quality with efficient resource utilization. 
• Review of the CSRs and any regulatory submissions. Co-leads the clinical operational team contribution along with Regulatory
• Responsible for the initial forecasting and management of all Clinical Operations delivery related costs and oversight for individual studies 
• Line management of CPM/Sr CPMs.
? Supports ongoing development of reports focused on building the skills base of Clinical Operations
• May act as a coach and/or mentor for other more junior staff, as required
 

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