Country Study Start-up Specialist Belgium

**Job Purpose/Summary**
- The Country Study Start-up Specialist supports the Regulatory Affairs-, Project Management
- and Legal-Team in the Study Start-up-phase and in case of Amendment submissions for Clinical Trials and Real World Evidence (RWE) studies. He or she is assisting with local regulatory country requirements, reviewing/preparing local submission documents and performing submissions.**What You’ll Do**

**Support of Regulatory Affairs Study Start-Up (RASSU) department**:

- Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level.
- Identifies the Central and Local Ethics Committees and Competent Authority needed for the study on the country level; processes pre-payments to Ethics Committees and Competent Authority; adapts study-related documents (e.g. Informed Consent Forms) to meet each local country’s specifications in cooperation with the RASSU Specialist assigned to the study.
- Serves as applicant for Clinical trials/RWE and may act as main point-of-contact for the Ethics Committees and Competent Authority and the assigned RASSU Specialist to the study on the country level.
- Communicates closely with RASSU specialist assigned to the study regarding EC /CA outcomes.

**Support the CTI Legal team**:

- Assisting with site contract translation; tracking the progress by updating and maintaining internal systems, databases and tracking tools (including the Trial Interactive database) with project specific information.

**Support Site Budget activities***:

- Identifies and establishes relationship with site personnel responsible for budget proposals.

**What You Bring**
- A minimum of 3-5 years of experience in Clinical Research (pharmaceutical, site or CRO service) and experience in regulatory in country.
- Associate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
- Ability to collaborate well in a global team environment
- Ability to maintain confidentiality
- Strong computer skills and proficient with the use of Microsoft Word, Excel, and Powerpoint)
- Ability to provide a superior level of customer service
- Strong working knowledge of GCP, EU regulations and ICH guidelines, Drug Laws on country level
- Excellent verbal and written communication skills
- Fluent in spoken and written language in Italian and English

**Why CTI?**
- We support career progression - 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
- We value education and training - We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
- We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade
- Our culture is unparalleled - Click here to learn more about “The CTI Way”
- We think globally and act locally - We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “CTI Cares” program)
- We are looking toward the future - We have had a consistent 15% growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate
- Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
- After an appropriate period of training, we offer you an unlimited, varied and attractive job in an international company.-
- ** in English**, as well as information about your earliest possible starting date and your salary expectation- CTI Clinical Trial and Consulting Services Europe GmbH
Frau Samy Weise
Schillerstrasse 1/15 | 89077 Ulm, Germany