Clinical Trial Manager, Late Phase Research

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.

Clinical Trial Manager, Late Phase Trials

Location: Singapore, Taiwan, Philippines, Hong Kong

SUMMARY

As the Functional Lead from Clinical Research Services with responsibility for delivery of all clinical aspects of clinical studies. To oversee and serve as the liaison between the Project Manager and a group of CRAs assigned to a given clinical study , for the delivery of all aspects of monitoring and site management , ensuring consistency with ICH/GCP and applicable ICON SOPs applicable regulations, the Monitoring Plan and ensuring the clinical portion of the study is inspection ready at all times.

JOB FUNCTIONS/RESPONSIBILITIES

Primary point of contact for Clinical Operations aspects of designated projects and responsible for developing successful working relationships with clients

Responsible for planning, scheduling and implementing the Clinical Operations aspects of projects

Contribute to the development and maintenance of cross functional project management plans

Responsible for risk mitigation strategies, associated action plans and issue resolution

Responsible for managing the Clinical Operations project team, including ensuring all necessary project training is provided to assigned staff

Provide direction and support to the Clinical Operations study team

Manage Clinical Operations aspects of projects in accordance with the contract including communicate any changes in Clinical Operations scope to the Project Manager and collaborate with Business Development to ensure timely completion of change orders

Track Clinical Operations project deliverables using appropriate tools

Effectively monitor and report on progress of the Clinical Operations aspects of projects to all stakeholders

Implement QC activities as necessary and monitor required quality metrics

Participate in business development activities, as appropriate including bid defense and proposal activities

Responsible for managing the Clinical Operations project team, including ensuring all necessary project training is provided to assigned staff

EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS

Experience in a Lead CRA/Project Lead or equivalent role and 6+ years of total experience in the clinical research field.

Experience in late phase and medical device studies would be preferred.

Successful industry experience, of clinical trial management and a proven understanding of the clinical operations aspects of projects and how they impact/interact with other functions

Thorough knowledge of ICH GCP and relevant regulations and a basic knowledge of the drug development and clinical trials process.

Proven leadership and ability to make complex decisions with minimum management oversight and work independently within the role

Experience in managing sites with in depth knowledge in local requirements and regulations in countries across the APAC Region

Knowledge of Clinical Operations processes and tools

University/Bachelor's Degree, or local equivalent, in medicine, science or equivalent degree/ experience

Fluent in written and spoken English.

Computer literate.

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.