Country Study Start-Up Specialist Belgium Milano

Country Study Start-Up Specialist Belgium
Milano
Lombardia, Milano

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