ICON Clinical Research Site Activation Lead - Medical Device in Helena, Montana
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.
The Site Activation Lead is responsible for ensuring the successful and timely activation of investigative sites to ensure that sites are activated in line with the study timelines and client expectation. The Site Activation Lead provides oversight for activities associated with substantial amendments as required. The Site Activation Lead is the functional representative of the Study Start Up department at the project team level.
Prepare/contribute to client and project specific site activation strategy and site activation plan and work cross-functionally to ensure that the sites and countries chosen optimize opportunities for successful delivery of the project for the benefit of the client and of ICON.
Ensure adequate oversight of project in terms of timely delivery of key timelines and that the impact of missed deliverables is understood by all key stakeholders.
Attends client calls, where required and ensures that both the interests of the client and of ICON are robustly defended.
Solicits the engagement and the contribution of key study stakeholders to ensure optimum performance and cross-collaboration.
Creates and maintains an environment of "trusted partner" which allows successful delivery of site activation through clear and open dialogue and use of "best practice" communication.
Invokes lessons learned and defines and uses other strategies/tools as required to assure optimized delivery and client satisfaction.
Support sales preparation materials and calls including bid-defense and study kick-off meetings where required.
Oversees day to day delivery of all aspects of site activation in the projects assigned.
Ensures that each project has a site activation plan and that the study is being conducted in accordance with that plan and in an effective manner which meets sponsor timelines and expectations and is in compliance with ICON/client KPIs, ICON/client SOPs, reporting norms, appropriate regulations and ICON's quality standards
Ensure that tasks associated with substantial amendments during the site activation and maintenance phase of the clinical trial are being coordinated and reported to a high standard and to the client satisfaction
Ensure effective resource planning and allocation within projects assigned.
Works with relevant management to ensure effective utilization and recovery of site activation resources within projects assigned and that those resources are budgeted and contracted.
Effectively embrace and foster change with respect to process improvement initiatives across site activation.
Works closely with peers to ensure global consistency in the successful execution of site activation activities & services across the SSU function.
Ensures that study performance is objectively & systematically measured and reviewed on a regular basis & reports status to relevant management
Manages and escalates any significant variations to study budgets, identifies out of scope activities and ensures to input into change orders as required.
Other duties as assigned.
What you need:
Bachelors' degree or local equivalent in medicine, science, or equivalent.
Experience in oversight of study deliverables, ideally with proven experience in the oversight of site activation project phase and/or staff in a global/multi-regional environment & familiar with GCP requirements
In-depth experience within clinical research with experience in the Clinical studies regulatory environment and a leadership role.
Significant leadership and well developed managerial skills demonstrating the following key Competencies:
Critical thinker and solution focused
Proactive & Delivery focused
Excellent planning and organizational ability
Proven decision making capabilities, analytical and data focused
Team focused & collaborative
Excellent negotiation & relationship building skills
Excellent conflict management skills
Excellent communication skills with demonstrated coaching and mentoring skills
Ability to successfully manage, positively interact and liaise successfully with all levels of staff at ICON, vendors, and clients.
Due to the nature of this position it may be required for the employee to travel, including air travel. Therefore, dependent on the employees' location, the employee may be required to possess a valid Drivers' license
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 through the form below.