Study Start Up Manager

6 maanden geleden

Utrecht, Nederland Icon plc Voltijd

**We are hiring for SSU Manager in Netherlands ( Amsterdam) (Homebased)**:
**Overview**:
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.

For our client in the Amsterdam region, we are looking for a **Study Start Up Manager **to join our ICON team

**Responsibilities**:
**What you will be doing**:

- Support country SSU strategy in close collaboration with SSO Study Start-Up team lead
- Accountable for timely start-up activities from country allocation until green light
- Ensures Study stat-up activities are conducted on time
- Prepares and finalizes local submission package for submission to IRB/IEC, CTA Hub as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs)
- Accountable for timelines, accuracy and quality of country TMF documents in study start up to ensure TMF inspection readiness

**Qualifications**:
**You are**:

- Must be based in the Netherlands
- Must have Start-Up experience
- Minimum 5 years experience in clinical project/trial manager role that oversees monitoring clinical trials
- Capable of leading in a matrix environment

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