Provide support for regulatory activities during study start-up in the assigned region. The primary focus is the preparation of documents for submission to ethics committees (EC) and competent authorities (CA), with a particular emphasis on adapting country and site-specific patient informed consent forms. Responsibilities include obtaining the necessary documents for submission and supporting the process until a vote or approval is granted. Close collaboration with CSL, CRA, and Project Manager is required for EC/CA communications.
Main activities are:
Prepare documents for submission to the Ethics Committee/Competent Authority (EC/CA) within the assigned region.
Initiate translation of documents as needed (e.g., Patient Informed Consent), review and adapt translations to appropriate language.
Develop country and site-specific patient informed consent forms according to regulatory and EC requirements and obtain internal approval where necessary.
Interpret clinical study protocols to support EC/CA submissions using layman’s terms where applicable.
Act as the point of contact for EC/CA inquiries and communications.
Support the approval process by adapting documents to meet EC/CA requirements and responding to queries.
Adjust budget to align with country and site-specific requirements.
Prepare submissions to other authorities as required.
Maintain local regulatory documents, both in paper and electronic formats, and ensure upload to the data management system (DMS) where applicable.
Provide support to the Clinical Study Lead (CSL) and clinical project teams.
Assist in developing and reviewing informed consent documents and patient information sheets to ensure all required elements are included.
Help collect site activation documents.
Qualifications
Relevant high school diploma or equivalent secondary education.
Bachelor’s or Master’s degree from an accredited college or university, or relevant experience in clinical research, medical devices, pharmaceuticals, or related clinical environment.
Proficient in using personal computers and various software packages, including Microsoft Word and Excel.
Experience with databases is preferred.
Native proficiency in German, with the ability to read, write, and communicate effectively, including clear, understandable speech, strong comprehension skills, and competence in German spelling, grammar, and punctuation.
Proficiency in English for reading, writing, and communication is also required.
Familiarity with cardiac, vascular, and neuromodulation technologies and clinical research processes is preferred, along with experience in the medical device or pharmaceutical industry.
Familiarity with German, Austrian, and Swiss regulations is desired, including knowledge of data protection and radiation protection.
Ability to handle sensitive and confidential information with discretion.
Capable of working independently when needed.
Strong communication and interpersonal skills to effectively communicate at various organizational levels.
Ability to multitask, prioritize, and meet deadlines.
Strong organizational and follow-up skills, attention to detail, and basic math skills.
What we offer:
We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers , eco vouchers, mobile phone (data included)
We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...)
Side activities will be organised regularly, to achieve a close collaboration within our team
We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
We contribute to a number of charities & support the research and / or the patients in our industry.
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