Summary:

The Vice President of Clinical Operations is responsible for setting the strategic direction and leading the successful execution and expansion of clinical trial operations across all of Javara’s healthcare partnerships, in keeping with our mission to deliver clinical research as a care option through unity and trust by enabling the integration of clinical research and clinical care to improve health and change lives.

Essential Duties and Responsibilities:

• Promote the mission of Javara with a primary guiding principle of patient safety and well-being and building and maintaining a culture that combines the highest standard of integrity with excellence to all those Javara serves.

• Accountable for Clinical Operations delivery across the Javara footprint, ensuring trial activity is conducted within timelines, budget and regulatory/corporate quality standards.

• Attract, develop, and retain leaders highly skilled in both Clinical Operations and people management.

• Provide leadership and strategic vision to clinical operations leaders and their teams. Ensure Clinical Operations leaders at all levels lead, coach, develop and mentor their team members to perform at the highest levels in keeping with Javara’s mission, core behaviors, study protocols, GCP, and company goals.

• Foster a collaborative, highly integrated culture where best practices and resources are shared across teams for collective success.

• Design and implement strategic and operational resourcing plans for Clinical Operations, ensuring Clinical Operations roles are filled with the right people, at the right time, with the right qualifications and commitment to Javara’s core values.

• Responsible for overall Clinical Operations budget and forecasting. Oversee development of operating budgets for clinical trial operations within the healthcare organization as well as budgets associated with clinical trials.

• Work with Clinical Operations leaders to identify solutions to maximize efficiency in study conduct, site management, training, technology and overall operations.

• Develop strong clinical operations partnerships with key clients and healthcare partners.

• Ensure clinical operations leaders are implementing enrollment strategies drawing upon healthcare partner patient access, Javara patient engagement center, patient marketing to deliver patient commitments.

• Work with Clinical Operations leaders to ensure programs and processes are developed and maintained that maximize research participant identification, enrollment, retention, and ongoing engagement, including training and accessing EMR to assess viability of enrolling in trials.

• Ensure Javara quality standards are implemented and upheld, and that Javara is “audit-ready” at all sites, at all times.

• Ensure Clinical Operations Leaders develop and foster collaborative and productive relationships with Investigators and other Healthcare Partner staff.

• Represent Javara on applicable professional association boards and committees to advance the clinical research profession, as requested by Javara senior leadership.

• Partner with the CEO, COO, and other senior leaders to ensure that all functions are aligned with the company’s strategic mission, values, and vision.

Qualifications:

Required

• Bachelor’s or Master’s degree in related field.

• Minimum of 10 years of experience leading a large clinical research operations organization or region with operations in dispersed geographic locations management experience.

• Minimum of 12 years of experience in clinical trial research.

• Deep understanding of clinical trial processes, FDA regulations and ICH/GCP guidelines.

• Strong familiarity with SOP’s, GCP’s guidelines and regulations pertaining to clinical trials.

• Ability to move between strategic and tactical in leading a team of experienced clinical operations leaders.

• Ability to lead cross-functional teams.

• Ability to take initiative, problem solve and work independently.

• Strong team player, collaborative and able to build an effective team.

• Excellent organizational and time-management skills, able to prioritize work to meet deadlines.

• Accountable, dependable and strong commitment to quality of work.

• Detail oriented with comfort working in a fast-paced environment.

• Strong written and verbal communication skills.

• Ability to use standard office software, as well as proprietary applications unique to the clinical trial industry.

Preferred

• Bachelor's or Master’s degree in Life Sciences or closely related field.

• At least 15 years of experience in clinical trial research.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• This job operates in a professional environment.

• The noise level in this work environment is usually light to moderate.

Physical Demands:

The physical demands described here are representative of those that must be met to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

• The employee will regularly use hands to reach, handle or feel objects, tools, or controls and talk and hear.

• The employee may frequently stand, walk and sit.

• The employee may occasionally lift and/or move up to 25 pounds.

• Specific vision abilities required include close vision, distance vision and the ability to adjust focus.

Travel: This position will involve regular travel to Javara corporate and site locations.

Pre-Employment Screening: Drug screen and background check required.

This job description covers the most essential functions of this position and is not designed to contain a comprehensive listing of activities, duties or responsibilities that are required of the employee in this job. Duties, responsibilities and activities may change at any time with or without notice.