Manager, Clinical Business Operations

Job Description

Job Description:\n\nThe START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. \n\nPosition Summary\nThe 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.\n \nWork Schedule: M-F, 8:00am-5:00pm\nLocation: 823 82nd Parkway, Suite B, Myrtle Beach, SC, 29572\n\nEssential Responsibilities\nClinical Activity Data Integrity\n\nEnsure 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.\nBridge 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.\nEnsure site clinical and operational data supporting START financial processes adheres to Master Data Management Governance standards.\nMonitor adherence to operational and financial controls established by START operational leadership to maintain clinical activity data integrity across all active protocols.\nIdentify 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.\nTrack 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.\nParticipate 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.\n\nSponsor Dispute Resolution and Invoice Support\n\nServe 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.\nWhen 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.\nWhen 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.\n\nFinance and Operations Partnership\n\nFunction 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.\nMonitor 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.\nTroubleshoot 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.\nProvide 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.\nCollaborate 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.\nWhen 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.\n\nPatient Billing Support\n\nServe 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.\n\nWhat the Role is Not\n\nDoes not create sponsor invoices\nDoes not process accounts payable or receivable (monitors AR status and supports resolution through data and documentation; does not own or execute AR transactions)\nDoes not own contract budgets or payment execution\nDoes not own data entry in Aria (EMR) or eDAR (pharmacy) -- those accountabilities remain with nursing and pharmacy leadership\nDoes not replace central finance, billing, or reimbursement functions\nIs not accountable for resolving cross-functional enterprise-wide process failures, but is expected to surface and escalate systemic issues\n\nOrganizational Structure\n\nOne Manager, Clinical Business Operations embedded at each clinical site\nAll site-based managers report to a Director, Study Operations (site-based)\nDotted-line collaboration with:\n\nRevenue Cycle\nContracts & Budgeting\nStudy Administration -- for CTMS build, budget overlay, and pre-activation alignment\n\nWhy This Role Matters \n\nImproves first-pass billing accuracy by owning CTMS data integrity and bridging EMR-to-CTMS translation\nReduces sponsor/CRO invoice rejections and rework cycle time\nEnables proactive error identification through KPI trending before issues reach AR\nProtects patient experience and trust\nCreates a single accountable owner at the site without fragmenting finance functions\nStrengthens the bridge between clinical operations and centralized finance\n\nRequired Qualifications\n\nBachelor's degree in Business Administration, Healthcare Administration, Finance, or a related field; or equivalent combination of education and experience\nMinimum 3 years of experience in clinical research operations, healthcare revenue cycle, or a combination of both\nWorking knowledge of clinical trial management systems (OnCore or equivalent CTMS preferred) and familiarity with EDC platforms and financial systems (NetSuite or equivalent ERP preferred)\nDemonstrated ability to identify and resolve data discrepancies across multiple information systems\nStrong written and verbal communication skills; ability to translate clinical activity data into business-relevant information for non-clinical finance audiences\nHigh degree of accuracy and attention to detail; comfort working with data reconciliation\nFamiliarity 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\nUnderstanding 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)\n\n \nPreferred Qualifications \n\nExperience working in Phase I oncology clinical research\nFamiliarity with sponsor invoicing and accounts receivable processes in a multi-site research organization\nPrior experience in a site-based role with cross-functional accountability to both clinical and finance leadership\nExperience with CTMS build, budget overlay, or charge master configuration processes\nCCRP, CRA, or equivalent clinical research certification\n\n \nCompetencies\n\nData integrity and systems thinking\nCross-functional communication and collaboration\nAnalytical problem solving and root cause identification\nKPI trending and continuous improvement mindset\nAccountability and follow-through\nDetail orientation under operational pressure\nSponsor and customer relationship management\nJudgment in escalation -- knowing when and how to surface compliance and systemic concerns across reporting lines\n\n \nPhysical Requirements/Travel\n\nThis 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.\n\nBest-in-Class Benefits and Perks\nWe 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:\n\nComprehensive health coverage: Medical, dental, and vision insurance provided\nRobust retirement planning: 401(k) plan available with employer matching\nFinancial security: Life and disability insurance for added protection\nFlexible financial options: Health savings and flexible spending accounts offered\nWell-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided\nPlus, 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.\n\nMore about The START Center for Cancer Research\nDeeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world.\n\nLearn more at STARTresearch.com.\n\nReady to be part of a team changing the future of cancer treatment?\nJoin us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.\n\nWe are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.