Associate Clinical Research Manager

Associate Clinical Research Manager
Empresa:

Bial


Associate Clinical Research Manager

Detalhes da Vaga

As part of the Clinical Research Department the selected candidate will be responsible to support phase IV clinical trials and late-phase clinical research at a local and international level.

Role/Responsibilities:

The key overall responsibilities of the role are as follows:
Support all activities related to Phase IV clinical trials.

Support and liaise with internal and external stakeholders the development of late-phase clinical research;

Perform co-monitoring visits to clinical sites and other activities to ensure the sponsor?s oversight of the Clinical Research studies;

Support the contact person for CRO/ clinical sites in matters related to Clinical Trials, finding solutions for existing problems;

Review and track all regulatory related documents and contribute for the organization of the Trial Master File;

Support in the organization of meetings with investigators;

Establish internal partnerships with all stakeholders involved in the process: Medical Affairs; Regulatory; Marketing, among others - allowing an alignment between the areas;

Participate and help to organize Advisory Boards, conferences and training in connection with the medical and regulatory teams;

Comply with the GCP applicable to the role;

Comply with the Quality, Environment, R&D and Health and Safety policies as well as other procedures or related guidelines;

Collaborate in other necessary activities that are required by the area/ department.

Requirements:

Bachelor's / Master's Degree in Health Sciences (preferred);

Previous experience in Managing Phase IV Clinical Trials (preferred);

Knowledge of Clinical Trials and related project management concepts;

Knowledge of Good Clinical Practices (GCP);

Excellent communication skills;

Fluency in English (spoken and written);

Good interpersonal skills and teamwork;

Autonomy, proactivity and good analytical capacity;

Strong Computer skills;

Availability to travel.


Fonte: Empregoxl


Área:

Requisitos

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