Clinical Operations Manager

"At ICON, it's our People that set us Apart"

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We differentiate ourselves by developing innovative solutions to bring life-saving drugs to market faster in a more cost-effective way with better patient outcomes. We are a top five CRO with solid earnings and growth potential. Our belief in excellence is our core value in all that we do for our sponsor partners and the patients that we serve.

ICON Clinical Research is Whole Owned Foreign Company which founded in 1990 in Ireland.

We expanded our business from 1995 in APAC region.

Currently we are hiring the Senior Manager, Study Start Up in Seoul, Korea.

As Study Start Up Manager, you will manage a global team of Study Start Up Associates across Korea team. The core purpose of this role is to coordinate, manage 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 eg 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

- To mentor and lead a team of around 20 Study Start Up staff in Korea, working with and through others.

- Lead and drive creation, review, and approval of Study Start Up related documentation

- Create and negotiate processes with Sponsors, Portfolio Directors, and other stakeholders as applicable

- 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.

Experience and Qualification

- 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 also have 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 of around 20 individuals, you will have strong mentoring skills, team management and team leadership.

- You will also have excellent communication skills both in Korean and English given that your role will have you chairing significant negotiation discussion with both internal stakeholders and external partners and sponsors.

Benefits of Working in ICON

In comparison with our competitor’s and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer’s to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market.

We are more like an extended family with consideration of staff as individuals allowing a work-life balance.

 You would be joining us at the very right time – just when we won the Best Contract Research Organisation Award at the annual Scrip Awards 2017.

If you would like more information please visit our company website: www.iconplc.com  or careers.iconplc.com. Or feel free to email me directly: [email protected]