For one of our clients, an international sponsor located in the north suburb of Paris, we are looking for an experienced Study Start up Specialist available for a 1 year project.
As Study Start up Specialist, you are responsible to support regulatory activities during the start-up phase of clinical trials in France : preparation of documents for submission to Ethics Committees (EC) and Competent Authorities (CA); country and site-specific Patient Informed Consent adaptation; collection of documents required for submission and support of the process until vote or approval is granted; EC/CA communication in close collaboration with CSL/CRA/Project Manager.
As Study Start up Specialist, you are also responsible and accountable for preparation, negotiation and signature of clinical contracts (including budgets) and amendments in France.
- You prepare documents for submission to Ethics Committee/Competent Authority (EC/CA) in the assigned region.
- You initiate translation of documents as applicable (e.g. Patient Informed Consent); review and adapt translations in an appropriate way.
- You prepare and adapt Patient Informed Consent form with Country/Site Specifications and according to Regulatory and EC requirements.
- You interpret clinical study protocols in order to support EC/CA submission.
- You act as point of contact for EC and CA.
- You support approval process (adaptation of documents according to EC/CA requirements; responses ….)
- You support budget adoption to country and site requirements.
- You are responsible to prepare submission to any other authority when applicable
- You maintain local regulatory documents on paper or electronically as applicable and ensure upload to data management system (DMS) were applicable.
- You provide support to the Clinical Study Lead/Clinical Project Teams
- You assist in the development and review of informed consent document/patient information sheet to ensure all required elements are included.
- You assist with collection of site activation documents.
- You adapt study site budget template to country and site-specific requirements
- You create, prepare, review and edit contracts, new work orders, amendments, modifications and change orders of a medium complexity level and contract risk type.
- You analyze document to determine corporate risk; prepares and provides alternative approaches to mitigate the risk.
- In compliance with Company policies, applicable regulations, Client Legal Department, you negotiate with sites.
- You work with Legal and other stakeholders (Compliance, Clinical Quality) on contract language such as indemnification, subject injury language, intellectual property rights, confidentiality, compensation, and other similar matters.
- You negotiate directly with research sites and ensure that the clinical trial budgets are in accordance with the clinical protocol requirements and associated Client policies.
- You review and approve country/site specific change of the Patient Informed Consents concerning Injury, Data Privacy and Compensation language involving specialists from other departments as needed
Do the above responsibilities fit you like a glove?
Download your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.
- You have a university degree and minimum 2 years of experience with clinical regulatory and contracting activities in France.
- You have relevant experience in clinical research or related device/pharmaceutical experience or relevant clinical experience in a clinical/hospital environment.
- You are bilingual French/English
- Proficient in using 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.
- A general familiarity with cardiac, vascular, and/or neuromodulation technologies, and clinical research processes is an asset.
- A full time position for a 1 year project
- Competitive salary with extra legal benefits
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy Number: 16145