Start-up Lead 2

1 week ago

Singapore ICON Full time

**Study Start Up Specialist**

**Singapore/Malaysia**

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
- Responsible for supporting the SRPs and investigator for Targeted Sites: Clinical Trial Site Activation & Conduct
- Assist with study site activation activities to ensure timely site activation
- Register investigator sites in Client registries, as required
- Support and/or coordinate central Investigator Review Board (IRB) submissions when needed.
- Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status.
- Support local IRB workflow from submission through approval and support reporting of updates to safety information
- Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner.
- Diploma or equivalent combination of education, training and experience; BS/BA or Bachelor’s degree in life sciences preferred.
- Experience in study activation and site management is an asset.
- Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
- Must be fluent in English, and the regulatory language of the appointed location
- Demonstrated knowledge of clinical research and development processes and ability to gain command of process details.

**Benefits of Working in ICON**:
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.

At 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.

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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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