For this position, you will be in charge of the following:
Responsible for coordinating and supervising the conduct of clinical studies
Plan and execute all operational aspects of clinical studies, and in accordance with approved clinical strategy, project plans, budget and ressources
Facilitate and train investigation centers/healthcare professionals on the specificities of the clinical study in which they participate
Monitor clinical investigations centers
2. Regulatory Compliance
Support development and maintenance of internal and external clinical study materials, processes, manuals, plans, committees, etc (e.g. clinical evaluation, clinical study documents such as protocols, reports, clinical publications,…)
Ensure the control, collection analysis and validation of clinical data in collaboration with Implicity’s teams (Data Science, Engineering, Product, RAQA, Marketing, etc…)
Develop and maintain the clinical quality system to ensure compliance with applicable regulations
Manage the safety reporting in clinical investigations
Ensure compliance of Clinical evaluation Report to the current applicable international standards and regulations
Master’s degree or PhD in engineering, science, bioengineering or similar
Experience
Minimum of 4 years of relevant experience in clinical research in a CRO or medical device or pharmaceutical industry
Has a prior experience as a clinical project manager or a similar role including extensive experience managing clinical studies from planning to completion
Technical Skills:
Experience with EDC systems for electronic data entry and management.
Ability to design and manage electronic case report forms (eCRFs) in collaboration with the data manager.
Speaks English fluently
Strong analytical and problem-solving skills.
Excellent attention to detail and organizational abilities.
Effective communication and teamwork skills.
★ If you believe that you are the right person for Implicity, we are looking forward to receiving your application through the Implicity page on “Welcome To The Jungle” website
★ We are proud to be an equal opportunity employer. We constantly challenge ourselves to build a diverse team of talents and to create an inclusive environment for all employees
★ Recruitment process:
HR Screen call (15min)
Interview with Giulia FAEDDA, Head of Clinical (1h)
Interview with Caroline Florequin, Head of Regulatory and Compliance (45min)
We are proud to cultivate a diverse and inclusive workplace. We enjoy the differences in experience, perspectives, and background. It makes it a better place to work.
Whoever you are, we will treat your application fairly.
💰 Remuneration
★ For this job (CDI - full time), your salary will depend on your experience.
★ Company equity
👍🏻 Benefits
★ Health care plan: Alan (26,5€ / month + 14€ for kids)
★ Luncheon voucher: 9€ (50% employer)
★ Transport: 50% of your pass OR sustainable mobility pass (37,5€ / month)
✅ Why us?
Simply because you will get all Scale-Up advantages without the usual drawbacks!
★ Activity: we are a “purpose company” - that really drives everyone’s daily motivation and commitment
★ Solution: we built a best-in-class solution, that has no direct competitor
★ Growth stage: we are not small - we are not big - we are 100 => our boom is to come
★ International: we operate at a global level, and our working language is English
★ Values: we do have values, and these are not just for posters!
- Integrity: we act with honesty and fairness
- Ambition: we strive for excellence in a healthcare demanding environment
- Cooperation: we care, we support, we seek collective success
Autonomy: you’ll definitely get real responsibilities, and have the chance to have impact
★ Employee care:
Our beautiful office is “rue du Louvre” (between Chatelet & Bourse)
Regular team events, especially every Thursday evenings
Our happiness manager (YOU) is taking the greatest care of all of us! 🐣
★ Tools: we used Slack, Notion and Google Drive, and it is pretty cool
★ Worklife balance: we are definitely respectful
★ Shareholder: you will be incentivized with company equity
Do you need more arguments? We’ve got a bunch!
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Paris · Nantes