Study Start Up Associate I, Taipei job in

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"At ICON, it's our People that set us Apart"

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. 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.

Job Description;

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 ethics and other bodies
Develop, finalize and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs)
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 Ethics Committee (EC) submission information, and similar information for other related.
Develop and maintain effective relationships with local, regional and country authorities
Travel(approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defences, Kick-Off, Investigator or study team meetings.

Requirements;

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 local 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
Customer service focused
Solution-focused
Bachelor’s degree or local equivalent and/or with appropriate experience from the Medical/science background and/or discipline

Compared with our competitor and pharmaceutical companies, we provide more flexible and reasonable working platform for coach and educate the new comer to be a professional person to concentrate on relevant industry. ICON also provides the good package and benefit to adapt the marketing development.

What’s Next

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity. ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment

A better career. A better world. A better you.

Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader.
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Study Start Up Associate I, Taipei

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