at DOCS in Little Rock, Arkansas, United States
Associate Director Study Leader, Early Global Development (Home-Based US)
Ref #: 28566
Employment type: Permanent – Full-Time
Location: United States – remote
Associate Director, Study Leader (early oncology)
LOCATION: Remote US
About the job
ICON 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.
What will you be doing?
• Leads the delivery of the clinical study from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards
• May convene and lead the cross functional study team(s) for Early Oncology Clinical studies based on delivery model
• Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate AZ manager or CRO representative
• Contribute to preparation and delivery of study documents (e.g. Protocols/amendments, Informed Consent Form (ICF) documents detailing study delivery data management activities, etc.)
• Responsible for forecasting and day-to-day management of study timelines, budget, materials and detailed study level plans and feasibility assessment
• Implement agreed study level process and technology for Early Oncology clinical studies
• Manage to the agreed study timelines, budget, and resource and ensure the update of appropriate systems
• Accountable for the quality of study planning information into relevant planning systems
• Guide the study team in the development of outsourcing specifications and vendor selection
• May manage the vendor(s) throughout the life of assigned clinical trial(s) based on delivery model
• Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
• Lead and conduct investigator meetings and other study related meetings
• Identify and communicate resource gaps for assigned studies
• Communicate study level reports and status updates for Early Oncology clinical studies
• Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
• Oversee the submission of trial-related and essential documents to the Trial Master File, maintenance and final closeout of TMF
• Ensure sponsor oversight throughout the life of the study
• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness
• Responsible for study level reporting of progress, risks and issues
• Provision to procurement clear specifications for study specific outsourcing
Review and operational approval of study specific contracts or work orders
What You Need to Have:
• Bachelor’s degree in related discipline, preferably in
medical or biological science
• Minimum of 5 years progressive experience in clinical research, with at least 3 years of clinical development project management experience or equivalent
• Comprehensive knowledge of the clinical and pharmaceutical drug development process
• Excellent knowledge of ICH-GCP principles
• Extensive and proven experience in driving operational delivery to timelines, cost and quality
• Proven experience leading delivery through internal and external organizations
• Experience and strength in working and leading in matrix teams
• Strong collaborative communications skills including the ability to engage with a diverse client base and manage through conflict
• Proven ability in problem solving and issues management that is solution focused
• Experience in providing clear requirements for external contracts
• Experience in selection of external providers and development/review of contracts
• Proven oversight of external providers
Benefits of Working in ICON:
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.To view full details and how to apply, please login or create a Job Seeker account