"At ICON, it's our People that set us Apart"
ICON plc, a leading global Contract Research Organisation employing 14,000 people in 40 countries. ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. www.iconplc.com
Clinical Trial Manager, ICO (Late Phase Studies)
Location: China
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 5+ 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 Philippines
- 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 :
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.