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Job Details

GSS II SPECIALIST (Study Start up Expert) / Rome, Italy

Company: Covance
Location: Rome, Italy
Reference: 68286BR
Closing Date: 20 Jul 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

COVANCE is one of the world's most dynamic drug development services companies, providing integrated, tailored solutions to the pharmaceutical and biotechnological industries. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.

Requirements:

Our mission - bringing medical miracles to market sooner - impacts the lives of millions of people all over the world. Our current growth of Clinical Development Services (CDS) in European countries brings new opportunities not only for clinical roles, but also another business functions.

At the moment we are looking for: Study Start up Expert in Rome.

As SSu Expert you will be responsible for developing project specific plans for the study start up component of assigned studies as well as for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance.

This role is assigned to CoSource Department, which means that you will be seconded to our client (Top 5 on the pharmaceutical market).

Sounds similar to the duties you currently do?

Responsibilities/Duties
• Act as resource for Associates; this includes but is not limited to prioritization of workload, addressing study specific questions, training and mentoring new Associates
• Assist in preparation of project specific plans for investigative site selection and critical documents collection & review
• Liaise with operational project team regarding project issues (i.e., participate in team meetings)
• Collect, review, process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP and ICH guidelines and the Investigator Package Plan
• Review 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 assigned Regulatory Department (Covance, Sponsor or both) regarding document submission requirements
• Maintain and update document tracking information in the site information module
• Manage site address and contact information (study supply shipping information / clinical study locations / site personnel)
• Assess impact of study personnel changes on regulatory documents and process new documents according to GCP/ICH guidelines
• Assess impact of study amendments on Informed Consent and other study documents and revise accordingly
• Prepare new investigator submission packages to Central IRB and liaise with them regarding submission/approval issues
• Provide milestone information for incorporation into weekly analysis sheets
• Monitor performance of 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)
• Manage set up and maintenance of investigative site files
• Understand and follow project specific and Site Activation Services policies and procedures
• 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)

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
• Good organizational and time management skills
• Excellent communication / writing skills
• Interact with internal and external customers with high degree of professionalism and discretion
• Exhibit general computer literacy
• 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


Keywords: Clinical Research, GCP, ICH, FDA, IRB/IEC, Regulatory, Study Start-Up Specialist, Study Start-Up Expert, GSS, GSS II, GSS Specialist, Rome, Italy

Apply for this job: GSS II SPECIALIST (Study Start up Expert) / Rome, Italy

Contact Information:

Address:  Covance- Warsaw


Poland
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