Company: inVentiv Health Clinical
Closing Date: 16 Dec 16
Type: Full Time
Salary (£): Negotiable
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry deliver new drugs and therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) is made up of more than 14,000 employees who have the ability to service clients in more than 90 countries. We offer a differentiated set of solutions designed to improve client performance and accelerate the process of bringing products to market.
inVentiv Health -Transforming Promising Ideas into Commercial Reality
Country Submission Specialist II, Netherlands
inVentiv Health Clinical is looking for an experienced Country Submission Specialist to join our dynamic team in France on a permanent basis. The position is a part of Essential Document Collection and Submissions (EDCS), Site Centricity Unit and provides country study start-up activities in support of assigned projects.
Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation, and provide updates of local processes and requirements to the Regulatory Intelligence portal.
Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
Compile and submit CTAs to Regulatory Authorities and IRB/EC (if applicable)
Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process.
Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.
Complete review of essential documents following Essential Document Checklist QC.
Arrange and review translations of relevant study documents.
Provide regular local status updates to project lead; update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems as required for assigned projects.
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
Support other departments as necessary
Identify site issues during start-up process, resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.
Train and mentor other associates on local regulations and internal procedures.
Complete assigned training programs and apply learning.
Complete necessary administrative tasks.
May perform other duties as assigned.
Prior clinical research/monitoring experience including study start-up experience
Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Strong organizational skills
Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
Must demonstrate excellent computer skills
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Fluency in English and French
Occasional travel may be required
Undergraduate degree or RN in a related field or equivalent combination of education, training and experience
In return we will offer:
A competitive remuneration package with excellent benefits.
A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization.
The opportunity to work within a successful and rewarding environment.
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