Job description
As a Clinical Study Administrator, you’ll provide essential operational support to clinical study teams within Clinical R&D and help ensure the quality, integrity and completeness of study documentation. You will be responsible for processing, tracking and filing study documents, managing the Trial Master File (TMF) and supporting project managers and clinical staff across assigned studies. In this role, you’ll contribute directly to the smooth execution of clinical projects and to continuous improvement of our clinical systems and processes.
Your missions
- Ensuring timely tracking of study essential documents and completeness of the Trial Master File (TMF) for assigned clinical studies, in line with regulations, departmental guidelines and work instructions.
- Building and maintaining (one)CTMS for assigned studies, including set‑up, tracking of relevant activities and ongoing data quality checks.
- Creating and distributing regulatory binders and wet‑ink signed document binders to study teams and sites.
- Supporting v‑TMF build and upload activities, ensuring accurate filing, version control and audit‑readiness of study documentation.
- Assisting study staff and investigators in resolving issues related to Study Files (TMF and Investigator Site File), and contributing to corrective and preventive actions.
- Facilitating internal communication of key clinical data and events to relevant stakeholders.
- Providing safety documentation to other functional groups in support of safety committee meetings, as requested.
- Supporting study supplies management (e.g. printing protocols, preparing and shipping materials, burning and distributing DVDs) when needed.
- Assisting with device tracking and ordering activities, if required and applicable to the study.
- Coordinating logistics for investigator meetings and expert panel meetings (e.g. invitations, materials, attendance tracking).
- Preparing and distributing study newsletters, including creating mailing lists from (one)CTMS and routing content for internal approval.
- Participating in process improvement initiatives related to (one)CTMS and v‑TMF, contributing ideas and feedback to enhance efficiency and compliance.
- Providing general administrative support for clinical study and departmental activities as assigned by the supervisor or study leaders (calendar support, documentation, minutes, follow‑up actions, etc.).
Your profile
- Minimum of a Bachelor’s degree in a scientific, medical, administrative or related field.
- At least 1 year of experience in administrative support or equivalent role; previous experience in clinical research or a clinical/medical environment is a strong plus.
- Solid proficiency with computer systems and Microsoft Office tools (Excel, Word, PowerPoint); experience with clinical systems such as CTMS and electronic TMF is an advantage.
- Strong tracking and follow‑up skills, with the ability to manage multiple documents, activities and deadlines in parallel.
- Excellent written and verbal communication skills, with a clear and professional style adapted to different stakeholders (study teams, investigators, internal functions).
- High attention to detail and accuracy in documentation, data entry and filing, with a strong focus on compliance and data integrity.
- Strong organizational skills, including ability to prioritize tasks, maintain structured files and support several studies simultaneously.
- Proactive, service‑oriented mindset, comfortable supporting cross‑functional teams and responding to operational needs.
- Ability to work both independently under general supervision and collaboratively within a multidisciplinary clinical team.
What we offer
Joining Amaris isn’t about joining a company where you simply wait patiently for a vacancy to arise. It’s about becoming part of an environment where your performance directly drives your career progression.
In practical terms, here’s what this means for you on a daily basis:
Projects worth your time 18+ months on average, with major accounts (Orange, Sanofi, SNCF, CMA-CGM…) and the support of our internal Centers of Excellence. You get the depth, not just the breadth.
Real management support 1 manager for up to 18 consultants, structured project check-ins, and a direct line to HR every month through Express Yourself. Our teams average 3.3 years of tenure — proof that we build something that lasts.
A career that actually moves 70% of our managers started at entry level. Average age: 36. Here, trust comes before experience and merit drives progression — not seniority. Functional (4 areas of expertise) and geographic (60+ countries) mobility are actively encouraged.
Innovation, in practice 291 AI agents built in-house, 250+ training modules, Microsoft certifications fully funded. At Mantu, AI stands for Artificial Intelligence — and Augmented Impact.
CSR with real targets SBTi carbon reduction roadmap, 32% women in management (target: 34.3% by 2029), social engagement through We Care Together.
Health insurance, remote work, meal vouchers, time savings account, referral bonus… We'll discuss the full benefits breakdown during our meetings.
Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
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Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!