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Senior Clinical Data Manager (Argentina)

April 29, 2026

As a Senior Clinical Data Manager, you will ensure that data captured in multiple clinical trials undertaken or managed by Indero is collected, managed, and reported clearly, accurately and securely. This role will be perfect for you if:<ul><li>You want to work on studies end-to-end (involved from protocol review to database lock)</li><li>You have the experience and confidence to lead multiple concurrent studies successfully as a Data Manager</li><li>You enjoy working directly with clients and forming recommendations as needed</li></ul> RESPONSIBILITIESData Management lead <ul><li>Monitor study status (ie. enrollment, CRFs monitored/approved, etc.) on an ongoing basis</li><li>Present deliverables to clients, gather feedback and propose solutions.</li><li>Provide regular data status reports to the project team</li><li>Oversee work of the Clinical Data Coordinator as required (quality, timeliness) </li><li>Oversee vendors to ensure that timelines and deliverables meet sponsor and protocol requirements</li><li>Is responsible for ongoing maintenance of the clinical database, including data review/cleaning during study conduct and during preparation for database lock/close.</li><li>Conduct reconciliation between external data and data in the EDC system to ensure consistency, including reconciliation with sponsor safety databases for adverse events/SAE (Serious adverse events) data</li></ul> Study setup – Technical <ul><li>Develop the data management plan (DMP)</li><li>Build a study-specific clinical database using the EDC system: </li><li>Design the electronic case report form (eCRF)</li><li>Build the clinical database in the chosen EDC independently or with the support of an EDC programmer (determined based on the complexity of the system and study. </li><li>Coordinate the validation and testing (UAT) of the clinical database</li><li>Support the study team with the development of external systems capturing clinical data (ePRO or IWRS), ensuring that any data transfer requirements between these systems and the EDC are documented and tested appropriately. </li></ul> User training and support <ul><li>Develop eCRF completion guidelines and other training material </li><li>Conducts training for site users/monitors on the clinical database</li><li>Activate/de-activate new users in the clinical database in response to requests from the project manager and maintain records of such request</li><li>Respond to users requiring assistance with the EDC system</li></ul> Database close/lock<ul><li>Generate data listings and reports needed for data review in preparation for database close/lock</li><li>Ensure that data management documentation is complete and up to date in the trial master file (TMF)</li><li>Archive the clinical database and related documents</li></ul> <h3>Requirements</h3> Education<ul><li>B.Sc. or M.Sc, or in a related field of study</li></ul> Experience<ul><li>7 years of clinical data management experience in the pharmaceutical industry or in a CRO environment</li><li>3 years of experience as a lead data manager</li><li>Extensive experience working with EDC systems (experience with Medrio and Medidata Rave preferred)</li></ul>Knowledge and skills<ul><li>Highly organized and detail-oriented</li><li>Project planning and time management skills</li><li>Strong verbal and written communication skills in English</li><li>Understanding of the drug development process and of applicable regulations, including Good Clinical Practices (GCP), ICH Guidelines</li><li>Good understanding of CDISC SDTM/CDASH standards</li><li>Knowledge of MedDRA and WHODrug dictionaries, an asset</li></ul> <h3>Our company</h3> The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: <ul><li>Flexible work schedule / work schedule :</li><li>Home-based position</li><li>Ongoing learning and development </li></ul> About Indero Indero is a contract research organization (CRO) specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Argentina <h3>Description de poste</h3> null <h3>Profil recherché</h3> null <h3>Notre entreprise</h3> null

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

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When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

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Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

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This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...