Site Management Associate

PSI CRO; Ciudad de México; Presencial; MXN 437.063 - 699.300; Jornada completa

Descripción de la vacante

PSI CRO is seeking a dynamic individual for a hybrid position in Mexico City, providing key support to clinical research projects. Your role will involve streamlining communication and managing essential documents for clinical trials.

The ideal candidate holds a College/University Degree in Life Sciences and possesses prior experience in Clinical Research. Strong communication, collaboration skills, and proficiency in English are essential for success in this role.

Formación

• Experience in administrative work, preferably in international settings.
• Prior experience in clinical research.
• Knowledge of local regulations.

Responsabilidades

• Act as the main contact for site personnel on project queries.
• Coordinate regulatory and ethics committee submissions.
• Manage TMF on site and country levels.

Conocimientos

Administrative work experience

Communication skills

Collaboration skills

Proficiency in MS Office

Full working proficiency in English

Ability to work in a dynamic team

Educación

College/University Degree in Life Sciences

Descripción del empleo

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.

Only CVs in English will be accepted.

Hybrid position in Mexico City.

You will be responsible for:

• Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion.
• Serves as the primary sites’ contact point for vendors, study supplies, and access management.
• Ensure that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed.
• Assists the Monitors in their prompt completion of all subject event and site event information in CTMS. Track the resolution status of site issues and action items in CTMS.
• Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.
• Ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions.
• Coordinate preparation for and follow-up on site, TMF and systems´ audits and inspections.
• Manage the TMF on a site and a country level for regularly and filedocuments. Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
• Arrange and track initial and on-going project training for site teams in all vendor-related systems.
• Document Management and translations status review of the study.
• Ensures proper safety information flow with investigative sites.

Qualifications

• College/University Degree in Life Sciences;
• Administrative work experience, preferably in an international settings;
• Prior experience working in Clinical Research;
• Local regulations knowledge;
• Full working proficiency in English;
• Proficiency in MS Office applications;
• Ability to planand work in a dynamic team environment;
• Communication and collaboration skills.

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.