Ref #: 25791

Employment type: Permanent - Full-Time

Location: Italy, Milan city

Posted: 16-Dec-2020

Description

Responsible for:
• Ensuring IIS are supported in accordance with global SOP and other supporting documentation
• Tracking of proposals and protocols and facilitating their review/approval
• Tracking of study budget, timeline milestones and payments to required standards
• Participating in set-up activities and sponsor support to the SOP
• Serving as a point contact for Global Clinical Program Management and TA/Medical Staff
• Assisting the Manager/Senior Manager/GSM management in support of activities including process clarification and issue resolution

Basic Qualifications
• Master’s degree OR Bachelor’s degree & 2 years of directly related experience OR Associate’s degree & 6 years of directly related experience

Preferred Qualifications
• BA/BS/BSc in the sciences or RN
• 5 years work experience in life sciences or medically related field, including 2 years of biopharmaceutical clinical research or clinical operations experience (experience obtained working on working on investigator-sponsored, industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO company)

Knowledge
• Ability to understand technical, scientific and medical information
• Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
• Understanding of drug development process
• Familiar with advanced concepts of clinical research
• Knowledge of relevant therapeutic or product area
• Advanced computer skills including databases
• Ability to write and present clearly using scientific and clinical issues terminology
• Experience dealing with time demands, incomplete information or unexpected events
• Good organizational and planning skills
• Experience with PRC and regulatory approval processes
• Experience working effectively in a team/matrix environment
• Experience in interactions with outside vendors, e.g. CROs and tertiary depots
• Experience with administration of budgets, contracts and payments

We offer a permanent, full time and partially client office based role.

To apply please send your CV to vera.stellino@docsglobal.com