• Providing input on strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), acting as a Core Team lead • Assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form • Determining if clinical trial/study subject documentation is within parameters of study hypothesis • Monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements • Participating and contributing to the development of clinical protocols, informed consent forms, and case report forms • Leading in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities • Acting as a mentor to new or junior level employees • Providing direction and guidance to execute project deliverables in collaboration with project managers • Identifying and evaluating clinical process improvement opportunities • Overseeing clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence • Participating in the development and validation of case report forms • Reviewing monitoring visit reports • Resolving complex trial/study data and regulatory documentation discrepancies escalated by junior level employees • Reviewing and completing checklist on informed consent forms (ICF)

Role Description This position provides direction and operational leadership of the clinical research studies to ensure delivery on time. The Clinical Trial Manager (CTM) is responsible for the management of clinical trials from study start-up activities through the clinical study report. The CTM drives completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates and resolves clinical study operational issues; and participates in process improvement initiatives as required. - Lead the end-to-end execution of CareDx clinical trials, including but not limited to: - Site identification - Study start-up - Study conduct - Monitoring and closeout - Drive site activation, enrollment, and overall study performance while ensuring alignment with protocols, operational plans, and business objectives. - Proactively identify study risks (timeline, quality, and operational), lead mitigation planning and execution, and escalate issues effectively with clear action plans, defined ownership, and accountability. - Conduct internal review of investigator contracts and payments, as necessary. - Provide cross-functional leadership across Clinical Operations, Data Management, Medical Affairs and other functional areas serving as the central point of coordination to ensure clear roles, accountability, and seamless clinical trial execution. - Prepare and present project debriefings to Clinical Operations management and cross-functional teams. - Oversee Clinical Research Associates, CROs, central labs, and external vendors to ensure high-quality, timely, and cost-effective deliverables through established governance, KPIs, and performance management processes. - Champion operational excellence by standardizing study execution models, optimizing vendor management and reporting frameworks, and implementing scalable process improvements and SOPs. - Ensure data quality and inspection readiness through proactive data review, performance metric tracking, and close collaboration with monitoring and data management teams. - Maintain strong communication with clinical sites and stakeholders, including oversight of site visits, study documentation, and reporting, while ensuring compliance with GCPs, regulatory requirements, and study protocols. - Support study administration activities such as site engagement, training, and product inventory management to ensure efficient and compliant study execution. - Ensure high-quality, inspection-ready documentation and study tracking through effective use of eTMF including oversight of TMF completeness, document quality, and real-time study status reporting. - Provide oversight and operational support for CTMS system and effective use of it for tracking study milestones, enrollment, monitoring activities, and performance metrics. Qualifications - Bachelor’s degree in life sciences, health sciences or equivalent degree/experience; RN or pharmaceutical experience preferred but not required. - Minimum of 4 years of clinical trial management and 2+ years clinical research associate with on-site/remote clinical monitoring experience in the biotechnology/pharmaceutical/CRO industry. - Robust understanding of ICH/GCP, and knowledge of regulatory requirements. - Working knowledge of medical terminology. - Experience with medical laboratory testing and documentation of patient information. - Comfortable with technology and scientific/engineering principles. Requirements - A critical thinker and capable of problem solving and aligning the priorities with study outcomes and timelines. - Strong clinical study/project management skills. - Excellent communication, written and organizational skills (ability to prioritize a number of tasks of varying complexity), along with problem solving, conflict resolution, leadership and team-building skills. - Ability to motivate and collaborate with teams at other functional departments. - Ability to work independently, take initiative, and meet company goals within timelines and budget. - Able to work in a fast-paced environment with multiple competing tasks and demands, across time-zones. - Must have a sense of urgency about problem-solving and completing projects. - Ability to communicate with vendors and keep a high quality of clinical study. - Strong knowledge of FDA regulations and GCP. - Proficient in Microsoft Office (Excel, Word, Outlook, PowerPoint), electronic data capture (EDC) software (Medrio, Medidata) and other platforms related to electronic Trial Master File (eTMF), CTMS and safety report. Benefits - Competitive base salary and incentive compensation. - Health and welfare benefits, including a gym reimbursement program. - 401(k) savings plan match. - Employee Stock Purchase Plan. - Pre-tax commuter benefits. - Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually for organ or bone marrow donation. - And more!

• Supervise, advise and review: Leverage your expertise. • Develop complex analysis strategies and execute them using efficient programming techniques (software: SAS, R). • Foster teamwork. • Perform intricate statistical analyses and provide input to statistical reports. • Share knowledge. • Provide input to analysis plans, statistical reports, statistical sections of integrated clinical reports. • Be a proactive advisor for all types of analysis from the proposal process through the project life cycle. • Review analysis data sets and quality control all types of statistical analysis deliverables. • Coach and mentor. Train and uplift junior members of the department. • Liaise with other biostatistical and company departments to optimize global efficiency.

Role Description The Clinical Research Finance & CTMS Specialist will support the financial, operational, and documentation needs of our growing clinical research program. This role will report to the Finance Department, while working closely with Clinical Research leadership, site managers, coordinators, investigators, sponsors, CROs, and external financial partners. Responsibilities - Clinical Research Finance - Support financial oversight of active clinical trials across Gastro Health research sites. - Track study revenue, earned revenue, open receivables, unpaid invoices, and outstanding sponsor/CRO payments. - Assist with sponsor invoicing, pass-through cost tracking, start-up fee tracking, milestone billing, visit-based billing, and closeout reconciliation. - Review study budgets and payment terms to ensure that billable items are properly captured and invoiced. - Monitor accounts receivables and assist with collections follow-up for unpaid sponsor and CRO balances. - Work with Finance and Clinical Research leadership to reconcile CTMS financial activity against internal accounting records. - Identify missed billing opportunities, underpaid items, payment discrepancies, and budget-to-payment variances. - Support monthly financial reporting for the research program, including revenue, collections, aging, and study-level financial performance. - Internal monthly reporting to clinical research sites on studies/performance, distributions, etc. - Assist in developing standardized finance workflows for clinical trial billing, invoicing, reconciliation, and collections. - RealTime CTMS Administration and Financial Tracking - Use RealTime CTMS to support study financial tracking, visit tracking, invoiceable events, payment status, and revenue reconciliation. - Ensure study budgets, visit calendars, invoiceables, and payment schedules are accurately entered and maintained in RealTime CTMS. - Partner with site staff to ensure completed visits, procedures, stipends, screen failures, unscheduled visits, and protocol-required activities are properly documented and financially captured. - Create and maintain CTMS reports to support Finance, Clinical Research leadership, and site-level operational review. - Identify gaps in CTMS utilization and help standardize how sites document visits, invoiceables, and financial events. - Support training of research staff on financial workflows within RealTime CTMS. - Research Billing and Collections - Support accurate research billing workflows by helping distinguish sponsor-paid services, standard-of-care services, pass-through expenses, and patient-billable items. - Assist with review of clinical trial billing activity to reduce missed charges, duplicate billing, or inappropriate patient billing. - Work with operational teams to ensure financial documentation supports billing and collection activity. - Coordinate with sponsors and CROs on payment status, invoice disputes, remittance details, and payment reconciliation. - Escalate unresolved payment issues to Finance and Clinical Research leadership as appropriate. - Help create a consistent process for tracking payments from invoice generation through receipt and reconciliation. - Source Document Development - Build and maintain protocol-specific source document templates for clinical trials. - Translate protocol schedules of assessments into practical visit worksheets, checklists, and source forms for site use. - Ensure source documents support clean data capture, protocol compliance, billing accuracy, and visit reconciliation. - Work with coordinators, investigators, and quality/regulatory staff to ensure source documents align with protocol requirements, EDC needs, and study workflows. - Update source documents when protocols are amended or operational needs change. - Support standardization of source document templates across Gastro Health research sites. - Cross-Functional Collaboration - Work closely with Finance, Clinical Research Operations, Regulatory, site coordinators, investigators, and external vendors. - Support communication between research sites and Finance to ensure timely and accurate financial reporting. - Assist with onboarding and training of research personnel related to CTMS use, source documentation, billing triggers, and finance workflows. - Participate in study start-up planning to ensure budgets, source documents, CTMS calendars, and financial workflows are established before activation. - Help build scalable infrastructure as Gastro Health expands its clinical research portfolio. Qualifications - Bachelor's degree in finance, accounting, healthcare administration, life sciences, or a related field preferred; equivalent experience will be considered. - 3-5 years of Clinical Research experience required. - Prior work in clinical research operations, clinical research finance, research billing, or CTMS administration. - Hands-on use of RealTime CTMS or a comparable clinical trial management system. - Tracking accounts receivable, payment status, sponsor collections, or study-level financial performance. - Development or maintenance of clinical trial source documents, worksheets, or visit templates. - Work with coverage analysis, charge review, payment reconciliation, or clinical trial revenue cycle workflows. - Work in GI, hepatology, IBD, MASH/MASLD, or other specialty clinical trials. - Work within a multi-site clinical research organization. - Understanding of clinical trial budgets, sponsor invoicing, visit-based payments, pass-through costs, screen failure payments, and start-up fees. - Ability to read clinical trial protocols, schedules of assessments, and study budgets. - Proficiency with Microsoft Excel, SmartSheets and standard business productivity tools. - Familiarity with clinical research compliance, GCP, HIPAA, and sponsor/CRO audit expectations. - Availability to travel as required. Benefits - Medical - Dental - Vision - Spending Accounts - Life / AD&D - Disability - Accident - Critical Illness - Hospital Indemnity - Legal - Identity Theft - Pet - 401(k) retirement plan with Non-Elective Safe Harbor employer contribution for eligible employees - Discretionary profit-sharing with employer contributions of 0% - 4% for eligible employees