Clinical Study Operations Specialist - Dynamic Team

Description:

Provides expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documents.
• With oversight from the Senior Director Clinical Programs, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions.
• Leads the delivery of the clinical study program(s) or study(s) from concept to final CSR and through to study closure and archive to agreed budget, time, project standards, quality and scientific standards.
• Accountable for overall study or program deliverables, maintaining oversight by close interaction with individual study leaders or leadership of the study team as appropriate.
• Implement agreed study level process and technology for Early Oncology clinical studies.
• Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalate issues to stakeholders as appropriate.
• Responsible for planning and leading issue escalation and resolution.
• Provide input to forecasting and management of study delivery costs, resource and timelines.
• Accountable for the quality of study planning information into relevant planning systems (e.g.: IMPACT, PLANIT).
• Guide the study team in the development of outsourcing specifications and vendor selection.
• Provision to procurement clear specifications for study or program specific outsourcing.
• Review and operational approval of study or program specific contracts or work orders.
• Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs.
• Communicate study level reports and status updates for Early Oncology clinical studies.
• Lead and conduct investigator meetings and other study related meetings.
• Identify and communicate resource gaps for assigned studies.
• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
• Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
• Mentors and supports development of individuals within the organization.
• Contributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators.