Clinical Trial Lead, Remote Italy

Dokumeds has become part of Rho, an award-winning, full-service CRO based in North America. As one company, we will deliver global full-service clinical development services and unmatched customer support – worldwide.

Because Rho recognizes great people are our most important asset, we attract and retain the best and brightest.

Here’s How We Do It

We are dedicated to a collaborative environment with fully integrated project teams and agile corporate leadership that ensures quick responses and follow-up. It is the combination of these elements that allows us to build and sustain an engaged and happy workforce. We are proud of our outstanding retention record; our talented employees tout work-life balance and close relationships with their colleagues and clients as primary reasons for joining our organization and growing their careers with us.

These are just some of the reasons Rho has consistently been thought of as one of the CRO industry’s best places to work.

By joining Rho, you will have the opportunity to work with some of the most talented minds in the industry to solve complex problems for our clients.

The Clinical Team Lead is integral to driving project success. This position will independently manage and lead the clinical team on select projects. This position will be responsible for providing direction to and training CRAs assigned to those projects. In addition, the clinical team lead is responsible for the oversight of all operational aspects related to the planning and management of CRA and site performance.

The Clinical Team Lead will be responsible for ensuring that sites and CRAs operate in compliance with study protocols, ICH/GCP guidelines, international and local regulations.

This is a remote opportunity.

Required to travel up to 25% of time, when needed.

Responsibilities

• Proactively drive project success, including working closely with Project Managers to develop and implement enrollment strategies
• Responsible for operational aspects of planning and management of site performance in accordance with departmental productivity expectations
• Develop monitoring tools and plans
• Determine and drive the study start up process (track and report progress, review data) ensuring that all sites are selected and supplies provided in accordance with study start expectations
• Provide skilled review of study protocols and other study materials (e.g. CRF)
• Monitor clinical operations timelines, metrics, resourcing, budget and activities
• Provide status updates to project management and sponsors
• Lead regular clinical team teleconferences
• Facilitate and supervise work with Site Study Coordinators
• Participate in the RFP process, including internal and external business development meetings
• Review monitoring visit reports and ensure finalization is within contractual timeline
• May assist Project Managers with project management tasks as assigned
• Create and conduct training sessions including investigator meetings, conferences, and team trainings
• Support the management and development of other CRAs
• Participate in the Clinical Operations community at Rho by leading key internal initiatives and standard operating procedures for the administration and monitoring the clinical trials

Qualifications

• 5+ years of clinical research experience within the CRO, pharmaceutical, or biotechnology industry
• At least 2 years of experience leading the clinical operations function within clinical trials
• At least 2 years of on-site monitoring experience

#ClinicalOperations