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 EC & CA submissions, site contract negotiations 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 site contract negotiations, 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 Drug labels
* Perform independent quality review of submission packages.
* Responsible for the translation and co-ordination of translations for documents required for submissions.
* 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 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
* 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