at DOCS in Dover, Delaware, United States
Director Study Leader, Early Global Development (Home-Based US)
Ref #: 30687
Employment type: Permanent – Full-Time
Location: United States – remote
• 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 Director, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions
• Leads the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards
• Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program by close interaction with individual study/program leaders or leadership of the study team as appropriate
• Ensure sponsor oversight throughout the life of the study
• 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/program delivery costs, resource and timelines
• Accountable for the quality of study/program planning information into relevant planning systems
• Mentors and supports development of individuals within the organisation
• Contributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
• Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
• Responsible for study or program level reporting of progress, risks and issues
• Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
• Provision to procurement clear specifications for study or program specific outsourcing
• Review and operational approval of study or program specific contracts or work orders
CON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
DOCS is an equal opportunity employer – Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.