Head, Clinical Research Network Operations

Job Title: 

Reports to:

Location:

Head, Clinical Research Network Operations

Chief Operating Officer

Flexible

Education Requirements

  • RN, BS, MS, PharmD or other advanced degree

Work Experience

  • 10+ years of experience in clinical research administration, site management, clinical trial delivery, including clinical research development, regulatory affairs and quality assurance metrics, portfolio management, strategic planning, drug development, healthcare administration and/or other related disciplines

Job Duties and Responsibilities

  • Identify, assess and onboard new sites for the I-ACT for Children network in North America and Internationally
  • Oversee interactions between Site Network Operations team and the individual network site’s leadership, site champions and others to identify needs and address issues and develop solutions including development and improvement of site infrastructure
  • Develop and oversee development of a site performance dashboard including metrics to measure operational delivery at the site level and prepare progress summaries
  • Provide ongoing site education and training
  • Engage with the executive team to develop site engagement tactics and plans
  • Initiate collaborations and maintain relationships with global pediatric clinical trial networks and consortia
  • Work with Site Network Operations team to deliver on sponsor projects and assure team is aligned with sponsor expectations
  • Serve as a consultant to Biopharma sponsors in the area of Site Management Operations as necessary
  • Provide oversight and guidance to Site Management Operations and Project Management Teams as they construct work orders to fulfill sponsor needs and expectations
  • Develop a site coaching and mentoring program
  • Oversee implementation of standard pediatric-specific GCP training within the network
  • Oversee the site Quality Improvement initiative within I-ACT for Children
  • Identify practical ways that the organization can add value in selected therapeutic areas, education and training, generalizable solutions and collaboration with other research organizations
  • Lead the evaluation of innovative study designs, utilization of quantitative science and other methodologies that improve quality, timeliness and speed in new product development
  • Conduct research, gather and analyze data and insights to stay abreast of scientific, clinical and regulatory dynamics in pediatric drug and device development
  • Serve on internal or external committees at needed

Supervisory Responsibility

This position will manage 2 – 5 direct reports as well as contract personnel and volunteers

Travel

Domestic and international travel:  up to 30%

Additional Eligibility Qualifications

None required for this position.

Salary & Benefits

Commensurate with experience and aligned with US benchmarked ranges for a research-based non-profit of this size and complexity.