Clinical Research Operations Manager

*Summary:*This position manages clinical research operations, including team supervision, trial processes, data management, and fiscal oversight. The role ensures adherence to regulatory standards (GCP, OHRP, FDA, IRB) and ethical research conduct. This position also involves strategic planning, business development, and the optimization of clinical trials operations.*About Us:*Pulmonix is an award-winning clinical trials organization integrated with Cone Health (Greensboro, NC) that is dedicated to transforming clinical care through cutting-edge research. Our expertise lies in Pulmonary, Asthma, and Critical Care Medicine trials, with a strong focus on Pulmonary Fibrosis (PF). PulmonIx has strong growth plans and the candidate is expected to work strategically with these growth plans*Structure: *Candidates will be hired at Cone Health in Greensboro, NC and leased to PulmonIx (also Greensboro, NC). Time management, attendance and compensation policies are governed by Cone Health. PulmonIx governs all aspects of work. Candidates will go through screening at Cone Health talent acquisition. Candidates will also go through screening at PulmonIxCandidates will have to go through rigorous pre-hiring process at PulmonIx that involves structured survey questions and multiple rounds of interview. Final hiring decision by PulmonIx.*Work Ethic:*Candidate must possess strong leadership skills to be an effective middle manager reporting to the executive team, holding direct reports accountable and be able to lead through delegation Complete alignment with the core values and executive team is required at all times. Candidates must be adaptable to change, rapid scale and possess remarkable skills in dealing with uncertainty. The candidate should support the growth and development of the research program, identifying opportunities for expansion, collaboration, and research excellence, and advocating for resources and suppor*t. As an exempt employee, the candidate should anticipate and embrace working much longer than the standard 40 hours. Candidate should be able to (context dependent) take calls or respond to work requests outside standard hours.**Essential Job Functions: *_- Operational Management:_ Manage daily operations of the Clinical Research site, ensure efficient trial execution and compliance with GCP, OHRP, FDA, and IRB guidelines._- Team Leadership_: Supervise clinical research staff, providing direct and indirect oversight. Oversee hiring, onboarding, resource management, and conduct performance reviews (CPR). Lead daily huddles, weekly meetings, and month project management meetings. Supervises multiple clinical trials_- Leadership Development: _Candidates should embrace and expect to go through leadership development as directed by the employer. This could include 360 degree assessments, conflict dynamic profiles, Hogan Assessments and coaching support._- Staff oversight: _will involve staff leased from Cone Health and also employed directly by PulmonIx. *Current Team Size: 17 (12 are full time and rest are interns, there are 3-5 PI and sub-I to manage as well).*_- Data Management: _Oversee the collection, compilation, documentation, and analysis of clinical research data. Review data from patient charts, medical records, interviews, and diagnostic tests. Ensure accurate and reliable data analysis._- Fiscal Oversight:_ Manage departmental and study budgets. Oversee working capital,accrual revenue, cash revenue, forecasting, revenue capture, accounts receivables, and accounts payable. Ensure financial accountability and efficient resource allocation. Present financial data regularly to the CEO._- Strategic Planning: _Collaborate with leadership to accomplish goals, support business development, and identify opportunities for program expansion. Develop and maintain standard operating procedures (SOPs)._- Performance Monitoring: _Work with leadership to develop Objectives and Key Results (OKRs) and monitor Key Performance Indicators (KPIs). Execute OKRs and KPIs through CPR meetings._- Technology and Process Management:_ Oversee Clinical Trial Management Software (CTMS) maintenance and expansion. Manage non-clinical inventory, procurement, shipping, and temperature logs. Ensure compliance with regulatory and operational protocols._- Patient Centered Approach:_ Background clinical knowledge and experience is highly preferred. Knowledge and ability to use patient central Electronic Medical Record (EMR) is required._- Mission & Values: _Fully aligned with the mission of PulmonIx (Company Values | PulmonIx Research LLC) this includes adapting to high growth. Be ready to excel our team to amazing heights and follow our core values. (Please note you are looking to work 40hour per week this is not the position for you, only serious applicants please)_*- Others: *_*Do jobs as required including flexing down to coordination and data entry**Experience: 5-7 years, including direct experience as a Clinical Research Coordinator, and within that 5-7 years ideally 1-2+ years as site operations lead.**Knowledge:* Strong knowledge of healthcare operations, insurance coverage, reimbursement, HIPAA privacy, medical revenue cycles, clinical trials processes, regulatory requirements, and industry practices. Fundamental knowledge of medical terminology (ICD-10).*Skills*: Ability to manage budgets and financial planning, excellent organizational, communication, and leadership skills. Proficient in office software (MS Office, Google Workspace, EPIC EMR). Ability to work effectively in a fast paced environment. Ability to delegate and manage multiple team members. Ability to align with management and possess organizational effectiveness. Ability to support high velocity growth maintaining the balance between quality and growth.*Licensure/Certification: **- Minimum: Certification in Clinical Research or Human Subject Research via ACRP or SOCRA**- Ideal/Preferred: Project Management or Certifications in Business Administration or Leadership *_Benefits: health, vision, dental, retirement_Job Type: Full-timePay: $38.40 - $57.60 per hourExpected hours: 40 – 50 per weekBenefits:* 401(k)* Dental insurance* Health insurance* Paid time off* Vision insuranceSchedule:* Monday to Friday* No weekendsExperience:* Clinical Research: 5 years (Preferred)Ability to Commute:* Greensboro, NC 27403 (Required)Ability to Relocate:* Greensboro, NC 27403: Relocate before starting work (Required)Work Location: In person

Created: 2025-08-12