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 fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Summary:
To coordinate, manage and facilitate the activities related to preparation, review and approval of country related and site level submissions in accordance with 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
Role Responsibilities:
• Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
• As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 25%) domestic and/or international
• Leadership: Sets a clear and convincing future direction, while communicating with clarity.
• Teamwork: Builds strong and effective teams, valuing different contributions; works with and through others, involving people in issues that affect them.
• Energizing & Developing Others: Creates an environment that motivates people; Identifies development opportunities for self and others; Acts as a coach and mentor and shares expertise.
• Delivery to Customers: Delivers high quality standards and strives for excellence; Acts in a proactive, flexible and responsive manner to customer needs.
• Building Relationships: Establishes good relationships internally and externally.
• Personal Effectiveness: Operates independently with a willingness to make decisions; Projects credibility and makes a professional and positive impression on others; Monitors progress and holds self and others accountable.
• Commercial Awareness: Understand the ICON business globally; Controls costs and thinks in terms of profit, loss and added value; Promotes ICON effectively in all interactions.
• Robust Thinking: Identifies the key elements of a situation and any gaps and inconsistencies in data. Makes rational judgements from available information and analysis.
• Observe the regulatory and EC/IRB environments and ensure the maintenance of an up-to-date database on EC and regulatory requirements
• Serve as Global Lead, as necessary
• Proactively identify and implement process improvement initiatives as appropriate
• Liaise with other managers within Clinical Operations to improve the effectiveness of the organization
• Liaise with colleagues from all other departments to improve the effectiveness of the organization
• Participate in business development activities and client meetings by assisting in the preparation and presentation of Clinical Operations information in Bid Defense meetings, Kick-Off meetings and business proposals
• Maintain confidentiality of management and personnel information, as appropriate
• Represent Clinical Operations in sponsor and internal audits
• Perform tasks and duties as assigned by Senior Management
Your background and experience:
You will likely have a blend of the following skills.
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 global team of cc 18 – 20 individuals, 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 quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON 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.
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