Rater - Part Time Contractor in Buenos Aires (La - IQVIA

IQVIA

Empresa verificada

Buenos Aires, Argentina

hace 2 semanas

Publicado por:

Sofía Rodríguez

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Descripción

Job Overview
Accountable for all aspects of the management and clinical execution of early/late phase clinical trials.

The Clinical Scientist (CS) leads the planning and implementation of all operational aspects of TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).

Essential Functions

Clinical Scientist for Phase I/II including multicountry / multicentre trials. The main focus will be on high complexity studies leading to clinical ProofofConcept or NDA registration.
Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress.
Lead all aspects of study planning and in collaboration with outsourcing/feasibility personnel, and others.
Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.
Coordinate the data analysis and interpretation of first interpretable results, publications and internal/external presentations.
Accountable for Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements.
Accountable for the set up and maintenance of the Trial Master File (TMF) for studies.
Contribute to the evaluation of clinical sites and external service providers for performing TM studies in healthy volunteers and patients.
Responsible for the coordination of preaudit activities for nominated projects ensuring a satisfactory outcome is achieved and address corrective actions.
Oversee and coordinate the work of assigned support Clinical Trial Associate(s) and Clinical Scientist(s) at the study/project level ensuring clear delegation/assignment of duties are documented.
Provide expert advice to other departments and line functions and to cross

- functional working groups as required.

Responsible for implementation of best practices and standards for trial management within TM, including sharing lessons learned.
Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of the sponsor's SOPs and internal policies.

Qualifications

Bachelor's degree in Psychology/Social psychology or Psychiatric Doctor (ideally). You can as well be a Master's degree in Psychology, or be a Psychoanalyst.
Experience with ratings in some specific scales.
Advanced level of English.
Availability to work parttime as a contractor and on site (La Plata).

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