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Job Details

Study Start-Up Specialist /Paris, France

Company: Covance
Location: France, Paris
Reference: 2018-19323
Closing Date: 09 Jun 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

Requirements:

Job Overview

You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. 

We are currently looking for Study Start-Up Specialist to join our Client’s team in Paris, France (La Défense).

Responsibilities assigned by the client within the Finance team, such as:
• Payment of invoices
• Manage and negociate contracts with investigators and hospitals with the respect of deadlines
• Prepare investigator budget payments and tracking systems; generate tracking reports as assigned
• Train and mentor Clinical Project Administrators
• Assist with coordinating vendors
• Organize/prepare for client meetings/teleconferences
• Assist/prepare for client or internal audits

Should also be able to
• Develop project specific plans for the Study Start-up component of assigned studies
• Liaise with operational project team regarding project issues (i.e., participate in team meetings)
• Collect, review, approve process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan
• Review and approve core English patient informed consents for compliance to international requirements and protocol as applicable
• Review and approve core Country patient informed consents for compliance to country requirements and protocol as applicable
• Review and approve investigative site specific patient informed consents for required elements
• Resolve informed consent and contractual language issues by exercising advanced judgment when interacting with study sites
• Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor 
• Liaise with Sponsor and Covance regulatory regarding document submission requirements
• Maintain and update document tracking, site address and contact information in the Site Information 
• Assess impact of changes in study personnel and document amendments on regulatory documents (including Informed Consent) and process/review/approve new documents according to GCP/ICH guidelines
• Assess impact of study amendments on Informed Consent and other study documents and revise and review/approve accordingly
• Prepare new investigator submission packages to Local and/ ot Central IRB /IEC
• Attend ongoing training in GCP, project specific requirements and as may generally be required
• Provide milestone information for incorporation into weekly analysis sheets
• Monitor performance of Study Start-up team with regard to project timelines
• Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying)
• Understand and follow project specific and Study Start-up policies and procedures
• Assume responsibility for the preparation and dissemination of documents according to the feasibility processes in place
• Create surveys to probe “thought leaders” and experienced researchers and clinicians in the field for expert feedback
• Assist with preparation of materials for formal client/industry presentations and for internal training assignments
• Apply basic understanding of data spreadsheets and tables
• Assist with entering data into spreadsheets when required
• Review and audit data tables and spreadsheets for feasibility assessments
• Conduct follow-up calls/telephone interviews with Investigators/Study Coordinators to solicit in-depth information related to feasibility and obtain further detailed information regarding potential proposals
• Prepare internal feasibility reports by summarizing information obtained during previous feasibility assessments, historical Covance study experience, and Investigator self-reported data
• Undertake literature and internet searches as required
• Mentor other Study Start-up team members
• Effectively manage multiple feasibility projects of varying levels of complexity within agreed turnaround cycles
• Directly manage day to day conduct with clients for standalone feasibility activities and other feasibility activities as appropriate
• Perform other duties as assigned by management

Education / Qualifications

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 1 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.

Experience

• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites

• Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
• Good organizational and time management skills
• Excellent communication / writing skills
• Strong computer skills with an ability to access and leverage technology alternatives
• Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
• Self-motivation with the ability to work under pressure to meet deadlines
• Works well independently as well as in a team environment
• Detail and process oriented
• Positive attitude and approach
• Multi-tasking capability 
• Ability to work independently

Apply for this job: Study Start-Up Specialist /Paris, France

Contact Information:

Address:  Covance -Geneva
7 Rue Moïse-Marcinhès, 1217 Geneva, Meyrin, Switzerland
1217
Switzerland
Website:  Visit Our Web Site

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