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