Clinical Research Lead Specialist H/F
il y a 3 semaines
Are you enthusiastic about Life Sciences and Clinical Research? Do you seek to thrive in a vibrant and collaborative international setting where your skills can make a significant difference in the lives of countless individuals? Join Aixial Group and play a vital role in the evolution of clinical research.
We are in search of a Clinical Research Associate (CRA) Lead to oversee and manage activities within clinical projects.
Key Responsibilities:
- Facilitate a comprehensive study initiation by leading the clinical team and working closely with other departments (Data, Regulatory, etc.).
- Ensure all preparatory activities are finalized prior to site initiation.
- Engage in training CRAs on specific operational study tasks.
- Support CRAs in organizing monitor and investigator meetings.
- Contribute to the creation and validation of all necessary documentation for the implementation of clinical activities (such as the study manual, monitoring plan, etc.).
- Review all monitoring visit reports.
- Collaborate with various service providers (CROs).
- Generate timely and relevant reports in the clinical trial management system (CTMS).
- Execute various study functions in partnership with the clinical project manager and clinical study assistant to ensure effective study execution.
Required Profile:
- Master's degree (PhmD - PhD) in clinical research or a related field.
- A minimum of 5 years of experience as a CRA monitor, including 3 years as a CRA Lead.
- Proficiency in the VEEVA system.
- Experience in oncology, rare diseases, or neurology in interventional studies.
- Fluency in both English and French writing.
- Exhibits autonomy, adaptability, organizational skills, and effective communication.
About Aixial Group:
- A global leader in Contract Research Organization (CRO), dedicated to delivering innovative and adaptable solutions to pharmaceutical, biotechnology, and cosmetic companies.
- Operating in multiple countries across various continents with a team of over 1000 skilled professionals.
- A member of the ALTEN Group since 2014, continuously seeking new avenues for global business growth.
What You Can Expect at Aixial Group:
- Engagement in pioneering projects that have a genuine impact on people's lives.
- Opportunities for continuous career and skill development with guidance and support from Aixial Group.
- Being part of an inclusive and diverse workplace that values dignity, respect, and individual differences.
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