Country SSU Spec (Level Depending on experience)

CTI Clinical Trial and Consulting Services; Leverkusen; Ibrido; EUR 55.000 - 75.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work opportunities

Descrizione del lavoro

CTI Clinical Trial and Consulting Services in Germany (Leverkusen) seeks a Regulatory Affairs Start-Up professional with 1–2 years of clinical research experience. The role involves submissions to Ethics Committees and Competent Authority, coordination with RASSU specialists, and handling study documentation in TMF systems.

You will support CTI’s Regulatory Affairs Start-Up, Legal team, and Site Budget activities, potentially working across local sites. Fluency in Italian and English is required.

Competenze

• 1-2 years of experience in Clinical Research and regulatory in country.
• Associate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science.
• Fluent in spoken and written Italian and English.

Mansioni

• Inform RASSU about changes in Drug Law/guidelines and country-level submission requirements.
• Review and prepare local submission documents and perform submissions to Ethics Committees and Competent Authority.
• Identify Ethics Committees and Competent Authority for the country and manage related payments.
• Serve as applicant for Clinical trials/RWE and main point-of-contact for EC/CA and RASSU Specialist.
• Coordinate with RASSU specialist on EC/CA outcomes and ensure proper TMF documentation.

Conoscenze

Clinical Research experience

Fluent Italian & English

Formazione

Associate’s or Bachelor’s Degree in allied health

Descrizione del lavoro

What You'll Do

• Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level
• Review/prepare local submission documents and performs submissions (Initial submissions, Substantial Amendments and Notifications etc.) to Ethics Committees (Central and Local) and to Competent Authority for Clinical Trials/RWE in accordance with local country requirements (e.g. via portal upload or mail or Email); and deliver final submission package to RASSU Specialist assigned to the study
• Identify the Central and Local Ethics Committees and Competent Authority needed for the study on the country level; process 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
• Serve 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
• Communicate closely with RASSU specialist assigned to the study regarding EC /CA outcomes
• Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper
• QC and QA of various study related Regulatory documents and reports
• Perform review, reconciliation, close-out, and archiving activities of study or project
• Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
• Attends internal and external study meetings and regulatory status reports for each site and country during study meetings

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
• Review/prepare local submission documents and performs submissions (Initial submissions, Substantial Amendments and Notifications etc.) to Ethics Committees (Central and Local) and to Competent Authority for Clinical Trials/RWE in accordance with local country requirements (e.g. via portal upload or mail or Email); and deliver final submission package to RASSU Specialist assigned to the study
• Identify the Central and Local Ethics Committees and Competent Authority needed for the study on the country level; process 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
• Serve 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
• Communicate closely with RASSU specialist assigned to the study regarding EC /CA outcomes
• Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper
• QC and QA of various study related Regulatory documents and reports
• Perform review, reconciliation, close-out, and archiving activities of study or project
• Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
• Attends internal and external study meetings and regulatory status reports for each site and country during study meetings

Support the CTI Legal team

• Foster relationships with key contacts at each site
• Facilitate contract-related communication between the site and CTI
• Assist with site contract translation; track the progress by updating and maintaining internal systems, databases and tracking tools (including the Trial Interactive database) with project specific information
• Identify any unique investigator, country or site-specific issues and identifying any ancillary agreements that may be necessary
• Assist with site contract execution

Support Site Budget activities

• Identify and establish relationship with site personnel responsible for budget proposals
• Interact with project management team members and clinical trials budget manager
• Has exact knowledge about site specific budget templates and experiences of completing such templates
• Train sites to understand budget templates and contents
• Understand and communicate changes made by the site to clinical trials budget managers and vice versa
• Assisting with translation, tracking the progress by updating the Trial Interactive database, sharing drafts and final versions with CTI personnel and delivering the final negotiated budget to site personnel

What You'll Bring

• 1-2 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
• Fluent in spoken and written Italian and English

About CTI

• Advance Your Career – We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.
• Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
• Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process