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Clinical project associate

Madrid
Indefinido
Becario
ROVI Pharmaceutical Company
Publicada el Publicado hace 21 hr horas
Descripción

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The Clinical Project Associate is in charge of assistance and support to all clinical research activities related to the projects assigned.

* Assistance to the Clinical Project Manager in the preparation, execution and closure of clinical trials.
* Assistance to the members of the project team in administrative, logistical and practical tasks, including follow-up, collection, distribution and presentation of the study documentation.
* Ensure adequate tracking and monitoring of all activities, documents and reports with the required format for delivery within the agreed deadlines.
* Request and review regulatory documents as required.
* Participate in the development of the study and the implementation of the process, including drafting and revision of study documents; clinical trial planning, ICFs, eCRF, organization and presentation at investigators meetings, and/or development of specific CRA project trainings.
* Support in the preparation of shipment of supplies related to the clinical trial.
* Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
* Conduct oversight visits for monitoring if required.
* Follow up and supervise the data collection of the ongoing study.
* Contribute to ensure effective project plans are in place for the study.
* Contribution to Monitoring and resolution of audit findings.
* Review financial issues and bill payments as defined in the study contracts.
* Scalate important topics or any potential quality issues to Clinical Project Manager and Clinical Operations Manager.
* Attend study meetings and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.

Searched profile:

Training:

University Degree in Health Sciences. Post-graduate studies in clinical research will be very valuable.

Languages:

Spanish: High level in reading, speaking and writing.

English: high level in reading, speaking, and writing (B2 or higher).

Experience:

At least 1 year in Clinical Research

Skills/Competence:

Excellent organizational and communication skills.

MS Office (intermediate-high level).

Occasional travel.

Seniority level

* Seniority level

Associate

Employment type

* Employment type

Full-time

Job function

* Job function

Research, Consulting, and Manufacturing
* Industries

Biotechnology Research and Pharmaceutical Manufacturing

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