Manager, Study Start Up

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

What you will be doing:

• Review study performance in each country within their remit and as applicable in each region, and instigate actions to improve performance
• Review study performance for every study led by a study authorization Lead from a country within their remit, and instigate actions to improve performance
• Ensure team compliance with ICON systems and procedures.
• Ensure that study authorization activities are in alignment with department metrics and goals
• Where necessary, support team in study start up related issues within his/her country/region
• Oversee management of submissions (start-up and ongoing) and study start-up activities (as applicable) to ensure they are conducted in an effective manner, meeting sponsor timelines, contractual requirements and expectations; and in adherence with ICON SOPs and appropriate regulations.
• Oversee management of studies in regards to Department goals set regarding quality, timelines and metrics
• Provide financial oversight to ensure appropriate profitability
• Monitor and manage staff workload to optimize resource utilization
• Effectively manage staff through open and timely sharing of information, regular performance review and feedback, and setting of clear goals and objectives. Ensure individual and team achievements are appropriately recognized
• Provide mentoring and training to staff ensuring that all necessary training is provided according to job title; act as a role model to team members
• Continually develop staff to reach their potential through evaluation and monitoring of their development plan
• Continually assess opportunities for process improvements and develop and monitor process change implementation
• Proactively participate in the selection and recruitment of suitable and qualified staff
• Develop supporting staff skills, encourage growth and provide regular performance feedback
• Assist with training for other departments as Clinical Operations representation, as necessary.

You are:

• Educated with a degree in Life Sciences and in depth proven clinical research industry experience.
• You will have had a career( up than 7 years ) 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.
• 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.
• High English level.
• Bachelor's Level Degree 

Why 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.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.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, colour, 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.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.