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Job Details

Associate Clinical Trials Manager

Company name
Vertex

Location
Boston, MA

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Job Description :

The Associate Clinical Trial Manager assists the Clinical Trial Managers in the conduct of trials and may be responsible for managing startup activities, vendor communication or other project activities as assigned. He/She performs work within established protocols under general supervision.

KEY RESPONSIBILITIES:

Assists with preparation of all external and internal documentation, for assigned trials, to ensure such documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocol, under close supervision

Assists Clinical Trial Manager in site management activities which could include review of monitoring report, tracking of site visits, communication with monitors and sites, and other activities as assigned

Maintains and tracks revisions to all documentation for accuracy, including patient Informed Consent Forms and

Case Report Forms

Assists the Clinical Trial Manager in ensuring compliance with Clinical Study Protocol and provides timely

updates to assigned Clinical Project Manager to confirm compliance

Organizes and prepares study files related to study tracking and reporting and submits them to the Trial Master File within established guidelines

May participate in the training of CRO teams, investigators and staff as needed regarding assigned logistics of the clinical trial

Tracks delivery and receipt of required supplies and materials to study sites and provides regular status updates

May mentor more junior Clinical Operations Staff or participate in the

on boarding

of new personnel

Performs other duties as assigned

Qualification:

Minimum Qualifications :

B.S. (or equivalent experience) and 1 – 4 years of relevant work experience

Demonstrates a working knowledge of ICH GCP regulations and clinical protocols

Exhibits ability to ‘multi-task’ effectively

Ability to interact well with various team members and provide

value added

support to

project

Displays ability to independently solve routine problems following standard policies/procedures

Company info

Vertex
Website : http://www.vertexinc.com/

Company Profile
Tax is a complex and time-consuming challenge for companies around the world. Constantly changing accounting and regulatory requirements, greater scrutiny from audit committees, and a shrinking pool of talent are all putting more pressure on the corporate tax function than ever before.

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