Clinical Research Associate Lead - M/F

Description du poste et des missions

You are a highly skilled professional with passion for the world of Life Sciences and Clinical Research? You want to thrive in a dynamic and collaborative international environment where your expertise directly impacts people lives?

Come and join Aixial Group to contribute to shaping the future of clinical research!

AIXIAL Group is looking for its next talented Clinical Research Associate Lead - M/F. Your missions will be as follows (non-exhaustive list):

- Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc…):

• Ensure feasibility report are exhaustive, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation,

• Support and ensure that all specific system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardizing the start of a trial.

• Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organization and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)

• Assist the study team in the evaluation of detailed timelines and establishment of clinical studies milestones for assigned projects, ensuring that they are performed to the most rigorous standards of quality and timely delivery.

• Prepare and/or assist in the production of all documents necessary to oversee the clinical activity implementation, monitoring and reporting in a professional, high quality and timely manner (such as monitoring oversight plan and clinical monitoring metrics…).

• Cuztomize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan

• Validate the final clinical study documents (such as study manual, monitoring plan …) prepared by the Clinical CRO.

• Review all/a sample of site visit reports as per the Oversight Monitoring Plan, ensuring timely and appropriate follow up of issues raised by monitors (Corporate & affiliates and/or CROs as appropriate).

• If applicable, provide support and guidance to Internal CRAs

• Coordinate and manage the CRO relationship, assisting CRO CRAs/CTLs when and where necessary.

• To set up regular meeting with MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical operations at various steps (site qualification, site recruitment)

• Co-monitor clinical studies according to the oversight monitoring plan, ensuring adequate contact with investigator sites, identifying and solving issues in study progress, verifying data in-house or by conducting co-monitoring visits, in collaboration with other study team members, and following up as required with CROs/CRAs/investigator.

• Participate in the ongoing clinical study data reviews in collaboration with the other study team members.

• Make appropriate and timely reporting ( Clinical Trial Management tracking System), with regular checks for quality and accuracy.

Who Are we?

• We are one of the world’s leaders in CRO (Contract Research Organisation) with the commitment, expertise, and flexibility needed to deliver efficient clinical trials.

• We work with global pharmaceutical, biotech, cosmetic, medical device, and many other companies around the globe, providing them with innovative and scalable solutions.

• We are operating in 10 countries across 3 continents, bringing together over 1000 talented professionals dedicated to make a positive impact in the life sciences industry.

• We have been part of ALTEN Group since 2014 and are continuously exploring new opportunities to expand our activity worldwide.

Why Join Us?

• Make a positive impact and be at the forefront of project:

You will be part of groundbreaking advancement in clinical research that has positive impacts on millions of people’s lives globally.

• Career Development:

People are our biggest asset. We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork. At Aixial Group, you will be coached and mentored throughout your journey to help you advance your professional and personal growth.

• Our commitment to Diversity, Equality, and Inclusion:

We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their best.

Gender equality is at the core of the development strategy of Aixial Group.

Aixial Group continues to grow, and to recruit in the clinical trial professions.

Join us, and discover our website to follow the news of our offers: https://www.aixialgroup.com/join-us/

For more information: https://www.linkedin.com/company/aixialgroup/about/

Compétences requises

• You hold a Master’s degree in Clinical operations or related field.


• You have at least 5 years of professional experience in Clinical operations.


• You are autonomous and possess professional maturity.


• You are fluent in English (spoken and written)


• You are based in France, Spain or Germany

Informations du recruteur

Lieu de la mission