Position Summary
The Manager, Clinical Business Operations is a site-embedded role responsible for ensuring the integrity and accuracy of clinical activity data recorded in START's systems of record. Primary systems include OnCore (CTMS), Aria (EMR), eDAR (pharmacy tracking), Filemaker, NetSuite (financial tracking), and sponsor-owned EDC platforms. The incumbent holds primary accuracy responsibility for CTMS and Filemaker data, and coordinates with -- but does not own data entry in -- Aria and eDAR, which remain the accountability of nursing and pharmacy leadership respectively. The incumbent coordinates with EDC systems but does not hold direct edit authority over sponsor-controlled clinical data. This individual serves as the primary interface between the clinical site and START's finance and operational leadership on all matters related to activity documentation, data accuracy, invoicing disputes, and revenue recovery. The role operates at the intersection of clinical operations and financial accountability, ensuring that every billable activity performed at the site is captured correctly, confirmable on demand, and collectable.
Work Schedule: M-F, 8:00am-5:00pm
Location: 4383 Medical Dr, San Antonio, TX 78229, United States
Essential Responsibilities
Clinical Activity Data Integrity
- Ensure that all clinical activity performed at the site in support of a clinical protocol is accurately and completely recorded in CTMS (OnCore) and Filemaker in a timely manner. Primary data entry accountability for these systems rests with this role and the study operations team; nursing and pharmacy leadership retain accountability for accurate clinical documentation in Aria and eDAR respectively.
- Bridge the translation between clinical documentation and billing system entry. Recognize that Aria and eDAR reflect clinical terminology (e.g., provider-ordered procedure names) while CTMS reflects the budget/CPT code construct established at study activation. Coordinate with clinical staff -- nursing, pharmacy, and study coordinators -- when CTMS entry requires interpretation of clinical documentation to ensure correct procedure coding and charge mapping. Engage Study Administration when build, budget overlay, or charge master alignment is needed to resolve terminology or coding discrepancies.
- Ensure site clinical and operational data supporting START financial processes adheres to Master Data Management Governance standards.
- Monitor adherence to operational and financial controls established by START operational leadership to maintain clinical activity data integrity across all active protocols.
- Identify and investigate data discrepancies where system records do not accurately reflect activity performed at the site. Initiate and document corrections in compliance with applicable site SOPs and regulatory requirements, with appropriate notification to the relevant protocol team and QA function. All corrections require authorization per established change control procedures; the incumbent does not hold unilateral edit authority over regulated clinical records.
- Track and trend data quality metrics, error rates, and invoice rejection patterns at the site level. Maintain a running record of recurring issues, root causes, and resolution actions. Report findings and improvement recommendations to the Director, Study Operations and revenue cycle leadership on a defined cadence.
- Participate in pre-study activation revenue cycle huddles for every new study and major amendment. Review CTMS build structure, budget overlay, and charge master mapping alongside Study Administration, revenue cycle, and site operations teams before first patient enrollment to prevent downstream billing errors. Capture and document key decisions in CTMS for reference as additional sites activate.
Sponsor Dispute Resolution and Invoice Support
- Serve as the site's primary subject matter resource when a customer (sponsor or CRO) disputes an invoice for accuracy or declines payment; provide finance and operational leadership with the specific site-level activity data needed to confirm or correct the invoiced services.
- When START has confirmed that services were performed and a customer dispute or non-payment is unwarranted: support downstream financial billing, accounts receivable, and collections processes by providing documentation and data confirmation required to support collections and secure cash receipt.
- When START identifies that an invoice to a customer may not accurately reflect services performed: support downstream financial billing and accounts receivable processes by facilitating timely correction of the source activity data and resubmission of accurate invoicing. Where read access to draft invoices is established, review outbound invoices for data accuracy prior to transmission. Proactively alert finance leadership when site data transmitted for invoice generation is identified as incorrect, whether before or after the invoice is sent; failure to flag known errors is a performance and compliance concern.
Finance and Operations Partnership
- Function as the site-level window through which central finance and operational leadership can access reliable, confirmable information about what clinical activity was or was not performed at the site for any protocol period.
- Monitor accounts receivable status for site protocols; track whether invoices are being paid, identify aging or disputed items, and escalate unresolved payment issues through Study Administration and revenue cycle channels. The role does not process AR transactions but is responsible for visibility into and follow-through on site-level AR status.
- Troubleshoot upstream data, process, and system issues that cause invoice rejections or billing errors before they recur. Primary upstream coordination runs through the Study Administration team for build, budget, and documentation alignment issues. Surface patterns to revenue cycle leadership for enterprise-level resolution.
- Provide input, trend data, and improvement recommendations to enterprise revenue cycle process owners and the Director, Study Operations. The role surfaces and documents systemic issues but is not accountable for resolving cross-functional enterprise-wide process failures; escalation of systemic issues to appropriate enterprise leaders is expected and supported.
- Collaborate with the Revenue Cycle team, AR and collections staff, and site clinical leadership to resolve billing exceptions, data gaps, and payer disputes in a timely manner. Work with peers in equivalent roles across other START sites to share recurring themes, effective practices, and resolution strategies.
- When site-level operational or financial controls are observed to be failing or not being followed, escalate findings through defined escalation channels to finance leadership, the Quality function, or senior operational leadership as appropriate. Escalation authority for data integrity and compliance concerns is not limited to the reporting line through the Director, Study Operations, particularly when the matter involves data gaps or control failures within that team's operational scope.
Patient Billing Support
- Serve as the site coordination and triage point for patient billing inquiries: receive patient billing questions, assess the nature of the issue, and route to the appropriate central billing or patient accounts resource for resolution. This role encompasses coordination and triage only -- substantive research billing compliance determinations, coverage analysis, and insurance adjudication are managed by START's central billing compliance function and are outside the scope of this position.
What the Role is Not
- Does not create sponsor invoices
- Does not process accounts payable or receivable (monitors AR status and supports resolution through data and documentation; does not own or execute AR transactions)
- Does not own contract budgets or payment execution
- Does not own data entry in Aria (EMR) or eDAR (pharmacy) -- those accountabilities remain with nursing and pharmacy leadership
- Does not replace central finance, billing, or reimbursement functions
- Is not accountable for resolving cross-functional enterprise-wide process failures, but is expected to surface and escalate systemic issues
Organizational Structure
- One Manager, Clinical Business Operations embedded at each clinical site
- All site-based managers report to a Director, Study Operations (site-based)
- Dotted-line collaboration with:
- Revenue Cycle
- Contracts & Budgeting
- Study Administration -- for CTMS build, budget overlay, and pre-activation alignment
Why This Role Matters
- Improves first-pass billing accuracy by owning CTMS data integrity and bridging EMR-to-CTMS translation
- Reduces sponsor/CRO invoice rejections and rework cycle time
- Enables proactive error identification through KPI trending before issues reach AR
- Protects patient experience and trust
- Creates a single accountable owner at the site without fragmenting finance functions
- Strengthens the bridge between clinical operations and centralized finance
Required Qualifications
- Bachelor's degree in Business Administration, Healthcare Administration, Finance, or a related field; or equivalent combination of education and experience
- Minimum 3 years of experience in clinical research operations, healthcare revenue cycle, or a combination of both
- Working knowledge of clinical trial management systems (OnCore or equivalent CTMS preferred) and familiarity with EDC platforms and financial systems (NetSuite or equivalent ERP preferred)
- Demonstrated ability to identify and resolve data discrepancies across multiple information systems
- Strong written and verbal communication skills; ability to translate clinical activity data into business-relevant information for non-clinical finance audiences
- High degree of accuracy and attention to detail; comfort working with data reconciliation
- Familiarity with regulated data environments, including an understanding that changes to clinical records require documented authorization and audit trail; experience working within change control or SOP-governed correction workflows preferred
- Understanding of clinical-to-billing terminology translation: ability to interpret clinical procedure documentation (e.g., EMR language) and align it to billing/budget constructs (e.g., CPT codes, CTMS milestones)
Preferred Qualifications
- Experience working in Phase I oncology clinical research
- Familiarity with sponsor invoicing and accounts receivable processes in a multi-site research organization
- Prior experience in a site-based role with cross-functional accountability to both clinical and finance leadership
- Experience with CTMS build, budget overlay, or charge master configuration processes
- CCRP, CRA, or equivalent clinical research certification
Competencies
- Data integrity and systems thinking
- Cross-functional communication and collaboration
- Analytical problem solving and root cause identification
- KPI trending and continuous improvement mindset
- Accountability and follow-through
- Detail orientation under operational pressure
- Sponsor and customer relationship management
- Judgment in escalation -- knowing when and how to surface compliance and systemic concerns across reporting lines
Physical Requirements/Travel
- This role is site-based and requires consistent on-site presence at the assigned START clinical location. Occasional travel to other START sites or corporate offices may be required for training, meetings, or operational support assignments.
Best-in-Class Benefits and Perks
We value our employees' time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:
- Comprehensive health coverage: Medical, dental, and vision insurance provided
- Robust retirement planning: 401(k) plan available with employer matching
- Financial security: Life and disability insurance for added protection
- Flexible financial options: Health savings and flexible spending accounts offered
- Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided
- Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.
