• Serve as the clinical program leader for one or more global, cross‑functional core teams—translating product strategy into executable clinical program plans and ensuring alignment with broader technical, regulatory, and business objectives. • Define and drive the clinical program roadmap, including strategy, requirements, milestones, and interdependencies across multiple complex studies. • Lead global study teams through all phases of execution—from early design and feasibility through study close‑out—ensuring scientific rigor, operational excellence, and compliance with worldwide Good Clinical Practice (GCP), ISO 14155, and other regional regulatory requirements. • Interface at a senior level with Executive Management, R&D, Regulatory Affairs, Quality, Operations, Marketing, and external partners/CROs to ensure technical and operational integration across program components. • Operationalize global clinical strategies, including study design approaches, regulatory evidence pathways, and site/country selection strategies informed by regional regulatory landscapes. • Oversee and manage complex program budgets, financial forecasting, and global resource allocation, ensuring optimal use of internal/external resources. • Establish and monitor KPIs for clinical execution, proactively identifying risks to study startup, enrollment, data quality, regulatory compliance, and program timelines—and driving mitigation strategies across global teams. • Lead vendor strategy and governance, including CRO and specialized vendor selection, contract oversight, performance management, and escalation resolution for multi‑region programs. • Implement innovative operational models and tools to optimize efficiency, quality, and scalability of global clinical execution (e.g., digital trial capabilities, centralized monitoring approaches, risk‑based quality management). • Represent the clinical program externally, providing senior‑level engagement with investigators, global KOLs, regulatory bodies (as appropriate), and other external stakeholders to ensure alignment on scientific and regulatory expectations. • Ensure integration of clinical insights into product development, partnering closely with R&D and technical program management teams to translate clinical outcomes into product improvements and future evidence needs.

• Work closely with the Head of Research and Community Health Operations and Head of Endpoint and Specialty Services to ensure overall quality of project services, proactive issue resolution and development of systems to standardize and improve project management practices as well as the whole ARO’s efficiency. • Serve as a mentor to other Clinical Operations Managers, including providing guidance on what efforts and activities are required to ensure the overall quality of project services and deliverables. • Oversee clinical operations management activities when delegated to a Clinical Trial Manager (CTM). • Manage site identification, evaluation, initiation, contracting/budget negotiation, and site monitoring processes as required by contract. • Identify the required regulatory documents for investigational product (IP) release and oversee documents collection. • Prepare central IRB submissions; oversee site IRB approvals and ensure collection of all new or expiring Investigator regulatory documents after site activation. • Oversee the development of project-specific essential documents for site oversight and development of site materials. • Review and finalize monitoring visit reports and follow-up letters with Clinical Research Associates (CRAs). • Work with CRAs on overall site management including identification, and resolution of site related compliance issues. • Prepare study enrollment reports and review site issues with the project team. • Manage and approve site payments as applicable. • Contribute to process improvement, including but not limited to review and/or development of SOPs, and development and/or implementation of methods to improve quality of sponsor deliverables. • Define and monitor project scope, timelines and deliverables from project initiation to close-out in collaboration with the Head of Research and Community Health Operations. • Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation. • Oversee trial-related activities and provide performance feedback to supervisors for all project team members. • Participate in the review, development and testing of study databases. • Provide investigational product or device tracking and disposition as required by project. • Develop and manage site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services. • Identify vendors and manage vendor services. • Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, monitoring plans and report templates. • Develop and manage multidisciplinary project team members. • Organize, plan for, and produce minutes for project team meetings. • Proactively identify project issues, propose resolutions to the project team, applicable heads of departments, CPC executives and/or the sponsor, and then track implementation of resolution through to completion and efficacy checks. • Ensure the overall quality of project services and deliverables. • Provide necessary updates and reports to the sponsor as outlined by the contract. • Plan and oversee the execution of investigator meetings as contracted. • Work with the business development team on budgets, proposals and change orders. • Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements. • Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. • Provide timely feedback to the Head of Research and Community Health Operations on the progress of project assignments. • Routinely advise management regarding the overall project status. • Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper. • Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). • Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented. • Supervise and evaluate performance of all staff reporting to this position, if applicable. • Additional activities as required.

• Responsible for the clinical operation function at the company and for representing clinical operations in cross-functional program teams, working closely with team leaders and other functional area subject matter experts • Accountable for the strategic planning and operational execution of clinical trials, ensuring they are conducted within agreed upon timelines, budgets, and regulatory quality standards. • Actively lead and/or participate in the development of clinical documents, including but not limited to protocols, ICFs, study manuals, investigator brochures, and clinical study reports. • Responsible for maintaining constructive interactions with clinical sites to ensure that all trials and programs have clearly defined plans, strategies, and milestones. • Actively lead the selection, management, and performance of study-related CROs, vendors, and external consultants. • Accountable for the management of clinical budgets. • Develop and maintain strong collaboration and communication with internal and external stakeholders, including regular communication of study-related metrics / KPIs to executive management and cross-functional study teams. • Promote a strong quality culture within Clinical Operations, ensuring clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/policies, and industry best practices. Participates and/or leads continuous improvement initiatives and collaborates in the development of Clinical Operations Standard Operating Procedures (SOP), Work Instructions (WI), training, and other tools to ensure compliance with FDA Regulations. • Lead responses to any audits as required (site, internal file, process, and regulatory agencies). • Develop and execute resourcing plans to ensure adequate and appropriate monitoring of all trials, including the evaluation and implementation of clinical technologies (e.g., EDC, eTMF, CTMS) appropriate for the company’s stage of growth. • Collaborate closely with CMC and Supply Chain teams to ensure clinical trial material (CTM) availability, stability, and proper handling/administration at clinical sites. • Provide accurate, current updates to executive management and program teams regarding the status of clinical trials.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description As a Clinical Documentation Quality Improvement (CDQI) Specialist, you will play a pivotal role in elevating the impact of our medical record documentation. You will conduct daily evaluations and engage in direct communication with providers to enhance documentation clarity, completeness, and overall medical record quality. By ensuring accurate and comprehensive physician documentation, you will be at the forefront of influencing the precision of code assignment, making a tangible difference in the accuracy of healthcare data. Join us in this critical role where your efforts will have a direct and meaningful impact on the quality and effectiveness of patient care. - Conduct timely, accurate, and complete documentation reviews for selected inpatient records, addressing inadequate or conflicting documentation. - Collaborate with physicians and caregivers to ensure appropriate reimbursement and clinical severity for DRG-based payer patients. - Demonstrate understanding of complications, co-morbidities, severity of illness, risk of mortality, case mix index, secondary diagnoses, and procedure impact on DRG. - Improve coding specificity by educating physicians and caregivers on the importance of clear documentation throughout a patient's stay. - Follow AHA guidelines and coding clinics for accurate coding and required documentation to ensure compliance. - Query physicians regarding missing, unclear, or conflicting health record documentation to obtain necessary details. - Maintain daily production logs for evaluation, tracking cases reviewed, queries placed/responded, etc. - Perform follow-up reviews to confirm recorded points of clarification in the patient's medical record. - Ensure confidentiality of all files, documents, and records. - Meet or exceed production and quality metrics. Qualifications - 3+ years of CDI experience - 3+ years of clinical experience in an academic medical center - Registered Nurse license, Bachelor's degree in Nursing - CCDS or CDIP certification required - Must pass a CDI skills competency assessment - Must be able to accommodate a min of 15 hours per week Requirements - Pay ranges for this job title may differ based on location, responsibilities, skills, experience, and other requirements of the role. - The estimated base pay range per hour for this role is: $40 — $45 USD Benefits - To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. - Requests for exemptions will be reviewed by Datavant Human Resources on a case-by-case basis. - This job is not eligible for employment sponsorship.