Study Start Up Associate I
ICON
Taipei
4天前

As a global provider of drug development solutions, our work is serious business. As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

Key responsibilities :

Prepare, review contract negotiation with external sites, working to project deadline to finalise study contracts

To be familiar with ICH GCP, relevant country regulations / guidelines and ICON SOPs

You will be collaborating with multiple internal and external teams to coordinate the contract templates and budgets throughout the timeframe

Completing contract amendment activities

Other study start up activities as required including : ethics submissions, creating submissions packages, amendments to study documentation according to country guidelines

To undertake other reasonably related duties as may be assigned from time to time

To succeed you will need :

Bachelor's Degree preferably in life sciences will ensure your familiarity with regulatory guidelines and industry knowledge.

Minimum of 1 year of experience or understanding of clinical study start up requirements and activities

Possess excellent written and verbal communication and interpersonal skills enabling you to deal with queries in a timely manner

You should be able to work autonomously, produce accurate work to tight deadlines within a pressurised environment

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