Manager, Study Start Up
hace 2 semanas
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by 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 Role:
As Study Start Up Manager, you will lead a team of Study Start Up Associates. The core purpose of this role is to coordinate, lead and facilitate the activities related to preparation, review and approval of Study Master, country related and site level Informed Consent documents in accordance with internal / external SOPs as applicable e.g. ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards; and to ensure that study authorization roles and responsibilities are focused on quality optimization, efficiencies and cost containment.- To mentor and lead a team of Study Start Up Associates, working with and through others.- Lead and drive creation, review, and approval of Informed Consent Forms / related documentation- Build and negotiate processes with Sponsors, Portfolio Directors- Deliver training to members of the team as well as global study teams to ensure quality and alignment of processes- Continually assess opportunities for process improvements and develop and monitor process change implementation.- Provide financial oversight to ensure appropriate profitability and monitor and manage staff workload to optimize resource utilization.
To be successful in the role, you will have:
- Educated with a degree in Life Sciences and in depth proven clinical research industry experience.- You will have had a career to date which will have included clinical trials allowing you to have an In-depth knowledge of the Informed Consent procedure (preparation, review and approval) from a regulatory perspective.- You will possess significant experience in the preparation, review and approval of Study Master, country related and site level Informed Consent documents in accordance with int./ext. SOPs as applicable, ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards.- In a highly regulated environment and tight timelines to open study sites you should have effective prioritization skills and ability to multi-task with meticulous attention to detail.- Given that this role will lead a team, you will have strong mentoring skills, team management and team leadership.- You will also have excellent interpersonal skills given that your role will have you chairing significant negotiation discussion with both internal and partners and sponsors.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That is 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.
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