Manager, Site Operations

JavaraFayetteville, NC
Onsite

About The Position

Javara is an integrated research organization (IRO) that advances value by integrating clinical research within the healthcare ecosystem. Javara brings better outcomes for patient centered care, better economic results, improved access to cutting edge therapies and a more predictable research delivery model to the biopharmaceutical sector. This role is responsible for promoting a culture that ensures patient safety and improves the patient experience. The Manager, Site Operations drives accountability for patient enrollment, ensuring Clinical Trial Navigators own the enrollment plan to meet recruitment goals. They ensure the highest standard of integrity, quality, and operational excellence in clinical research activities, adhering to SOPs, GCPs, protocols, OSHA, IRAs, and other applicable regulations. This role positively impacts engagement, retention, and the employee experience by demonstrating core behaviors for people managers in three key pillars: Engage & Inspire, Drive Success, and Empower & Develop. The Manager, Site Operations recruits, trains, manages, and coaches Site Operations team members, ensuring they meet expectations. They maintain a staffing plan for resourcing and utilization of site operations team members for multiple locations or larger sites to achieve performance objectives, identify opportunities or gaps, and implement plans accordingly. They oversee the standardized utilization of systems, data entry, and clinical trial operations best practices. The role cultivates, maintains, and develops strong long-term relationships with investigators and practice staff, providing insight on the best clinical trials for their patient population. They maximize research participant identification, enrollment, retention, and ongoing engagement by developing programs and processes, including training and accessing EMR to assess viability of enrolling in trials. This position may manage multiple sites or satellite site locations. They provide high-quality client support to build credibility and trust while meeting the needs and strategic objectives of healthcare partners, sponsors, CROs, patients, vendors, and colleagues. The Manager, Site Operations manages study and site performance, including developing and adhering to an operating budget for clinical trial operations within the healthcare organization as well as budgets associated with clinical trials. Other responsibilities may be assigned.

Requirements

  • 2+ years’ experience managing a clinical research site and team or equivalent relevant management experience.
  • 5 + years’ of clinical trial research experience including hands-on application of clinical functions such as obtaining vitals, EKG’s, and phlebotomy.
  • Associates or Bachelors Degree or equivalent educational experience.
  • Experience applying leadership approaches such as situational leadership, servant leadership, and transformational leadership for people management.
  • Experience using business acumen to develop strategies to achieve and exceed expected results.
  • Project Management

Nice To Haves

  • Degree in Life Sciences or related field highly beneficial.

Responsibilities

  • Promote a culture that ensures patient safety above all and improves the patient experience in everything we do.
  • Drive accountability for patient enrollment, ensuring Clinical Trial Navigators own the enrollment plan to meet recruitment goals for their specific studies.
  • Ensure the highest standard of integrity, quality, and operational excellence in clinical research activities, with adherence to Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), protocols, OSHA, Integrated Research Agreements (IRAs), and other applicable federal, state, and local regulations.
  • Positively impact engagement, retention, and the employee experience by demonstrating the core behaviors for people managers in three key pillars: Engage & Inspire, Drive Success, and Empower & Develop.
  • Recruit, train, manage, and coach Site Operations team members and ensure they meet expectations in accordance with role expectations and company goals.
  • Maintain a staffing plan for resourcing and utilization of site operations team members for multiple locations or larger sites to achieve performance objectives, identify opportunities or gaps, and implement plans accordingly.
  • Oversee the standardized utilization of systems, data entry, and clinical trial operations best practices.
  • Cultivate, maintain, and develop strong long-term relationships with investigators and practice staff and provide insight on the best clinical trials for their patient population.
  • Maximize research participant identification, enrollment, retention, and ongoing engagement by developing programs and processes, including training and accessing EMR to assess viability of enrolling in trials.
  • May manage multiple sites or satellite site locations.
  • Provide high quality client support to build credibility and trust while meeting the needs and strategic objectives of healthcare partners, sponsors, CROs, patients, vendors, and colleagues.
  • Manage study and site performance including developing and adhering to an operating budget for clinical trial operations within the healthcare organization as well as budgets associated with clinical trials.
  • Other responsibilities as assigned.
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