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Manager of Clinical Operations


This is a Contract position in The Woodlands, TX posted September 14, 2020.

Summary: The Manager of Clinical Trial Operations is a specialized research professional responsible for the comprehensive operational and relationship management of clinical trial activities associated with Javara’s healthcare partnerships.

With a guiding principle of research participant safety, the Manager of Clinical Trial Operations is responsible for promoting the mission of Javara and ensuring that the strategic integrity of the relationship between Javara and the healthcare organizations within their region are upheld.

Therapeutic areas of research include multi-specialty, inpatient and outpatient trials.

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 Recruit, train, manage and mentor Clinical Trial Operations team members; ensure team members perform to meet expectations in accordance with job descriptions and company goals Assist the Director/VP in the strategic planning, administration, and operation of all clinical research activities conducted by Javara within the healthcare organization Ensure the strategic goals and objectives set forth between Javara and the healthcare organizations are attained Comply with the terms outlined in the Integrated Research Agreement between the healthcare organization and Javara Ensure that quality measures are being obtained, and population health initiatives are being promoted and followed Assist the Director/VP in cultivating relationships with new prospective clinical research providers within the healthcare organization and provide high quality client support to build credibility and trust Work alongside the Director/VP to establish, cultivate and maintain strong long-term relationships with the healthcare organizations, identifying, developing, and implementing marketing and outreach plans, presentations and strategies designed to grow the partnerships between the healthcare organizations and Javara Work alongside the Director/VP in managing the allocation, sharing and efficient utilization of clinical trial resources to achieve performance objectives, while ensuring quality and consistency Ensure clinical trial team safety, regulatory compliance, and that Javara’s standard operating procedures and guidelines are followed, as well as ensuring that all team members comply with all FDA, ICH/GCP Guidelines and state and local laws and regulations Oversee uniform application of clinical trial technology systems, policies, and procedures Assist with identifying types of clinical trials that will align with population health strategies and financial objectives of the healthcare organization Oversee and/or conduct pre-qualification visits, site initiations and study closeouts with sponsor representatives, including proactive engagement for feedback regarding site performance Assist the Director/Vice President with development of an operating budget for clinical trial operations within the healthcare organization as well as budgets associated with clinical trials Assist and/or develop programs and processes that maximize research participant identification, enrollment, retention, and ongoing engagement, including training and accessing EMR to assess viability of enrolling in trials Assist with onboarding of new technology when appropriate Coach and mentor staff to establish career pathing and ensure opportunity for growth; foster and maintain a positive, results-oriented work environment Partner with the operations leadership team to ensure that all functions are aligned with the company’s strategic mission, values, and vision Qualifications: Required Minimum of 1 year of experience managing a clinical research site/team or related management experience Understanding of clinical trial processes, FDA regulations and ICH/GCP guidelines Ability to adhere to and apply SOP’s, GCP’s guidelines and regulations pertaining to clinical trials Experience with project management 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 degree in Life Sciences/related field or educational commensurate At least 5 years of experience in clinical trial research Travel: This position may involve up to 20% travel with most travel within their region, as well as applicable visits to Javara headquarters in Winston Salem, NC.

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.