A client of SciPro's is looking for an Associate Director of Clinical Operations (IRT) to join their team on a 40 hr/wk, 6-month initial contract.

They're a global, innovative biopharmaceutical company focused on inflammation and allergy therapeutic areas. They’ve got two approvals under their belt and are advancing a broad pipeline of trials from early to advanced stage.

This candidate will be responsible for the IRT system, advise on the development of the study protocol, and coordinate with the Clinical Operations Study Lead and ISO lead.

Responsibilities:

• Assist in the selection of the IRT vendor for each project
• Set-up and maintain the IRT system with a focus on the supply of study sites
• Review UAT scripts prepared by Quality Systems and Compliance
• Perform UAT for each study, and determine the amount of staff needed to execute the UAT scripts
• Perform on-going IRT supplier oversight
• Provide guidance and training to study teams on the handling of study medication and the IRT system
• Collaborate with the ISP and COSL to review the pharmacy manual elements that effect the IRT system
• Ensure compliance with SOPs, GxP, and ICH guidelines in addition to legal and ethical standards

Requirements:

• 8+ years of clinical operation experience
• Bachelors degree or equivalent
• Extensive knowledge of interactive response systems and trial management
• Extensive knowledge of GCP and GMP guidelines
• Excellent Communication Skills
• Excellent Leadership Skills

Logistics

• 6-month initial contract
• 40 hrs/wk
• Hybrid: Cambridge, MA

This is an urgent need, and SciPro has done 5 contractor placements with this client over the last 2 years.