For one of our clients, a medical device company, we are looking for a bilingual Junior Site Regulatory Submission Specialist (German - English) to come on board and join their team. This person will be responsible for clinical trials in the DACH region (Germany, Austria, Switzerland).
Job Description
The Submission Specialist supports regulatory activities at study start up in assigned region (DACH). The focus is on preparation of documents for submission to ethics committees (EC) and competent Authorities (CA), especially country and site-specific Patient Informed Consent adaptation; obtain documents required for submission, and support the process until vote or approval is granted. EC/CA communication in close collaborate with CRA and Project Manager.
Responsibilities
- Prepare documents for Ethics Committee/Competent Authority (EC/CA) submission in the assigned region (DACH).
- Initiate translation of documents as applicable (e.g. Patient Informed Consent); review and adapt translations to appropriate verbiage.
- Prepare Country/Site Specific Patient Informed Consent form according to Regulatory and EC requirements and obtain internal approval where applicable.
- Interpret clinical study protocols in order to support EC/CA submission where layman terms are required
- Point of contact of EC /CA
- Support approval process (adaption of documents according to EC/CA requirements; responses ….)
- Support budget adoption to country and site requirements.
- Prepare submission to any other authority when applicable.
- Maintain local regulatory documents on paper or electronically as applicable and ensure upload to data management system (DMS) were applicable.
- Provide support to CRA / Clinical Project Teams
- Assists in the development and review of informed consent document/patient information sheet to ensure all required elements are included.
- Assist with collection of site activation documents.
- Other Activities
- Attend project related meetings; schedule room and teleconference, create an agenda and write meeting minutes as applicable.
- Performs other related duties and responsibilities, on occasion, as assigned.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Complies with all regulations in force, Company policies, operating procedures, processes, and task assignments.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
- Ability to notify supervisor if timelines appear to be at risk so that more resources can be added to assist.
- Able to handle multiple assignments in a timely manner while meeting assigned deadlines.
- Serves as a liaison to Clinical Site Management and site personnel for administrative questions
- Maintenance of Clinical email box and dissemination of emails to relevant team members to ensure response to queries
- Assist team personnel with site activation and closure activities.
- Assist in communication of other study activities
- If applicable, de-identify and file adverse event source documents.
Requirements
- Bachelor's or Master's degree from an accredited university or college
- Fluent in German (C2 level) and in English (C1-C2 level)
- Experience within clinical research or medical devices is a strong asset.
- Proficient in operating a personal computer and in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software.
- Experience with Databases is desired.
- Ability to use discretion and handle sensitive/confidential information.
- Ability to work independently when necessary.
- Ability to exchange straightforward information, ask questions, and check for understanding.
- Ability to multitask, prioritize and meet deadlines.
Contract Information
- Full-time position (min. 80%)
- Office-based position, 4 days/week (Brussels/Zaventem) with 1 day/week of homeworking
- Permanent contract
Vacancy number: 24873
