Senior Start-Up Specialist

Job Overview:

Across the globe, we keep intact our commitment to improve health and improve lives, and are looking for exceptional people who are eager to play an important role pushing new frontiers in how we diagnose, monitor and treat patients.

Our Drug Development business continues to support and meet the needs of our pharmaceutical and biotechnology client partners: we continue to initiate new studies from Early Development through Phase IV, and our Central Labs are fully operational.

In this spirit, we would like to introduce you an unique job opportunity in Italy for an experienced Study Start up Specialist / Site Activation Associate , to work sponsor dedicated for a Top 5 global Pharmaceutical company.

This job is home/ office based in Rome, Italy .

THE START UP/ SITE ACTIVATION JOB

In this job, you will have a significant impact on how Portugal can deliver country-specific Start up commitments and objectives. You will oversee local operational Start up activities in the following areas for your assigned protocols:

Financial: Assistance with the ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements and clinical and financial contracts within fair market value. Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out.

Country Submissions & Local Language materials: Responsible for execution and oversight of clinical trial country submissions and approvals. Development of local language materials including local language Informed Consents and translations.

Qaulity Oversight: Country deliverables, timelines and results for assigned protocols to meet country commitments. Quality and compliance in your protocols, contributing to the development of local SOPs.

Local Process Oversight: Oversight and coordination of local processes. Problem solving and Process Improvement is essential to this position (i.e., issues with budget / CTRA negotiations, Quality and Compliance, Regulatory and legal issues or related to functional area deliverables that could jeopardize protocol milestones.)

WHAT MAKES THIS JOB SPECIAL: COLLABORATION

This will be a enriching opportunity because, on top of the above experience,  you will work in close collaboration:

  Internally with the Clinical Country Operations team of managers, CRAs and CTCs, but also Quality Managers, Finance, Medical Affairs, Regulatory Affairs, PharmacoVigilance, Legal  and regional operations & Head Quarter functional areas. Externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.

Covance are Practicing Social Distancing with Video Interviews

All your interviews with us will be conducted via phone or using WebEx video. To help you prepare, check out this brief guide for best practices and WebEx guidance:

https://www.labcorp.com/labcorp-enterprise-video-interviewing-guide Education/Qualifications:University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (nursing certification, medical or laboratory technology) Thorough knowledge of ICH Guidelines and GCP, including a basic understanding of regulatory requirements in Italy Thorough understanding of the drug development process Fluent in Italian & English Experience:

For this job, we can consider candidates with:

  Significant clinical Start up/ Site Activation experience in a sponsor/CRO (minimum 2 years)   Working knowledge of ICH, FDA, Portuguese regulatory requirements, IRB/IEC and other applicable regulations/guidelines Familiarity with investigator start up documents; previous interaction with operational project team and investigative sites