Ref #: 30753

Employment type: Permanent - Full-Time

Location: Spain

Posted: 18-Jul-2021

Description

Description:

Maintains liaisons with clinical research organizations or internal clinical trials administration and operations department to initiate and expedite clinical studies on products that have investigational new drug or medical device approvals

Monitors reporting systems to look for trends and/or issues in the data/study conduct metrics.

Analyzes/summarizes the data for reporting

Supports compliance with global health authority regulations and guidelines an internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the SMT operate in a constant state of inspectionreadiness.

Work With Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools

Support staff, as appropriate, in the set-up and coordination of Investigator Meetings, if applicable. Presentation of training materials at internal/external training opportunities

Supports team by monitoring budgets and expenditures as required by trial budget and expectations.

Support availability of required reports to manage/ensure real time tracking of trial status according to Trial Plan

Profile:

University/Bachelors Degree or Equivalent
Minimum of 3 years clinical trial execution experience in the pharmaceutical industry
Requires clinical research operational knowledge, project planning/management and communication skills.
Good working knowledge of ICH, GCP and FDA guidelines/regulations
Solid understanding for the drug development process with a special emphasis on clinical development
Ability to multi-task
Excellent computer skills

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Why join the ICON GSS team at ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
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