- Design, prepare and lead clinical studies, including planning, execution, analysis, reports & close-out.
- Lead final study site selection, contract process, site initiation visits and training of site personnel on study protocol, database, and investigator responsibilities.
- Develop and execute the clinical study monitoring plan, with interim and risk-based monitoring visits. Review data and support database development and maintenance with third parties.
- Responsible for selecting, assessing and managing third party vendors and CROs for quality management, regulatory, etc.
- Be the clinical development expert in product development workshops.
- Prepare scientific rationale for clinical/regulatory documents.
- Prepare literature updates.
Have you been in a clinical development/operations team for a few years, know the industry well, but struggle to find promotions to develop your management skills because of corporate culture? Do you care about femalehealth and developing better, faster, and less invasive solutions to improve our healthcare system? We are looking for an energetic individual who wants to grow with our company, who is tired of countless alignment calls before a decision can be made and who likes to see projects go from start to finish. Somebody who likes wearing many hats and is not afraid to go from giving directions, to rolling up their sleeves and being hands on. If this would make you wake up proud and full of energy every day, then this is the job for you! QUALIFICATIONS:
- PhD/medical degree and 2 years of relevant experience (clinical study development/operations in IVD, medical devices, companion diagnostics, or CRO experience) or science degree and 4 years of relevant experience.
- Knowledge of GCP (certification a plus) and of EU regulatory requirements for design, control and clinical study management (US requirements is a plus).
- Experience working with data management tools and understanding of databases and general statistical concepts.
- Understanding of Electronic Data Capture (eDC), eTMF and CTMS or similar clinical operations systems.
- Experience of authoring clinical study documents (Protocols, Investigator Brochure, Informed Consent Documents etc) is desirable.
- Able to develop appropriate internal and external technical expertise required and coordinate efforts to resolve technical issues that may arise during clinical trials.
- Experience in clinical research certification (such as CCRA, CCRC) is a plus.
- English proficiency is a must, and French or Spanish fluency is a plus.
- – Able to travel ~20% of time depending on clinical study needs.
Intitulé du poste proposé
Clinical Lead H/F
Poste basé à EVRY COURCOURONNES
Secteur d’activité : Recherche & développement
Nature du contrat : CDI
Disponibilité : Dès que possible
Niveau d’études : Bac+5 et plus
Rémunération envisagée : à définir selon le profil
At EndoGene.Bio, we want to bring high level precision medicine to female health. We are working on reducing the time for endometriosis diagnosis from years to weeks thanks to proprietary biomarkers found in menstrual blood. We believe in doing what is right, not what is easy. We are scientifically driven, daring and believe that hard work and kindness are unbeatable. We want our people to grow with us. We are diverse and we encourage you to use this job to take your career in your hands! We want you to try new things, shadow others and take up courses. Your win is our win. We work as a community and work to empower and lift everyone who helps us in our journey, from patients to physicians to industry advisors. Our community is
our superhero. We are going to build a legacy in female health, and we want you in our team.