Study Start Up Associate II job in

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ICON Clinical Research is Whole Owned Foreign Company which founded in 1990 in Ireland. We expanded our business from 1995 in APAC region.

Currently we are hiring the Study Start Up Associate II in Australia.

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a SSU you will be responsible for the independent preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards Also responsible for the independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory/sponsor requirements – within specific timelines and quality standards. Developing and finalizing Master and Country Specific Information Sheets/Informed Consent Forms (SIS/ICFs)

Role Summary

Serving as a primary contact for investigators and research coordinators, you will perform feasibility, site identification, site contract negotiation and other assigned study startup activities. This will include the preparation, review and approval of country related ethics/regulatory submission packages and site level critical documents for Investigational Product (IP) release. Some travel is anticipated, to attend Kick-Off, Investigator and/or study team meetings..

Role Responsibility

• Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned

• Provide country specific Study Start Up expertise to Study Start Up Team Leads and project teams.

• Responsible for the preparation and coordination of submissions to regulatory, ethics and other bodies

• Develop, finalize and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs)

• Review and translate Drug labels

• Perform independent quality review of submission packages.

• Responsible for the translation and co-ordination of translations for documents required for submission.

• Perform timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system

• Copy and route incoming correspondence, internal documentation, etc., as appropriate

• Responsible for the timely follow-up for queries made by EC/CA

• Responsible for the collection of critical documents required for IP Release

• Responsible for the timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system in assigned countries Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA)and Ethics Committee (EC) submission information, and similar information for other related.

• Develop and maintain effective relationships with local, regional and country authorities

• Comply with all department requirements regarding information provision and status updating and reporting

• Travel(approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defences, Kick-Off, Investigator or study team meetings.

Experience and Qualification

• A minimum of 2 years of hands on experience in Clinical Study Start-up area

• Knowledge and experience in the clinical study start up requirements and activities for all assigned countries (or the ability to find this out for new countries)

• Good organizational skills and the ability to manage multiple tasks

• An excellent level and proven experience high standards of attention to detail

• Good written and verbal communication skills. Proficient in English and language required for country assignments

• Ability to liaise with colleagues from Study Start Up, other departments and clients, if required

• Strong project management skills

• Highly developed problem solving skills

• Strong people management and effective communication skills

• Customer service focused

• Solution-focused

• Bachelor’s Degree or local equivalent and/or with appropriate experience from the Medical/science background and/or discipline

Benefits of Working in ICON

In comparison with our competitor’s and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer’s to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market.

We are more like an extended family with consideration of staff as individuals allowing a work-life balance.

You would be joining us at the very right time – just when we won the Best Contract Research Organisation Award at the annual Scrip Awards 2017.

If you would like more information please visit our company website: http://www.iconplc.com/ or careers.iconplc.com. Or feel free to email me directly: ramjee.narasimhan@iconplc.com

Application process

Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.

Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.

One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.

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Study Start Up Associate II

About the role

This vacancy has now expired. Please see similar roles below...

ICON and you

ICON history

Career Pathways

Benefits & Rewards

DE&I

Environmental, Social & Governance

Women in IT

Application process

Who we are

Government and public health services

Why icon? full service mean for you?

Study Start Up Associate II

Send me a message

About the role

This vacancy has now expired. Please see similar roles below...

ICON and you

ICON history

Career Pathways

Benefits & Rewards

DE&I

Environmental, Social & Governance

Women in IT

Application process

Who we are