{"id":3065981,"url":"https://alion.io/job/advancell-associate-director-trial-operations-budget","title":"Associate Director, Trial Operations & Budget","company":{"id":2044873,"name":"AdvanCell","domain":"advancell.com.au","url":"https://alion.io/company/advancell","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":75,"open_postings":3,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-11-15T07:52:55Z"}},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Boston, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":170000,"max":220000,"currency":"USD","period":"year","gross":null,"usd_annual":220000},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-07-31T21:31:45Z","employer_posted_date":"2026-07-31","last_verified_at":"2026-11-15T04:56:24Z","board_verified":true,"closed_at":null,"days_open":106,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":105},"description":"The Associate Director, Trial Operations & Budget is responsible for supporting the oversight, planning, and execution of clinical trial activities, with a strong emphasis on financial management and operational excellence. This role ensures that clinical operations deliverables related to CROs, vendors, and clinical sites management and oversight, including budgeting, contracting, invoicing, and Trial Master File (TMF) quality and completeness verification-are conducted in alignment with corporate financial and clinical operations SOPs, study protocols, ICH/GCP guidelines, regulatory requirements, and established budget and timelines. Reporting to the VP, Clinical Development and Operations, this position plays a critical role in vendor management, financial stewardship, and the delivery of high-quality, efficient clinical trials.\nKey Responsibilities and Duties\nResponsibilities will include, but not limited to:\nDevelop, manage, and track site and study budgets in collaboration with CROs and internal Finance partners. \nReview, reconcile, and approve vendor and CRO invoices against contracts, milestones, and deliverables. \nSupport clinical operations contracting processes, including review of scopes of work, vendor agreements, and amendments. \nManage and review change orders, ensuring alignment with scope, timelines, and budget. \nGenerate and maintain purchase orders (POs) in accordance with company processes and study budgets. \nSupport vendor selection, onboarding, and ongoing performance management to ensure adherence to KPIs and contractual commitments. \nSupport oversight of CROs to ensure clinical trials are executed according to timelines, quality standards, and contractual obligations. \nConduct and/or oversee quality control of the Trial Master File (TMF) to maintain accuracy and continuous inspection readiness. Monitor TMF completion metrics to ensure timely and comprehensive document completeness.\nCollaborate closely with cross-functional teams including Finance, Legal, CMC, Pre-clinical to ensure seamless execution of clinical programs. \nProactively identify risks in study execution and financial management, and implement mitigation strategies.\nSupport onboarding procedure and training on internal processes for new team members.\nOther Responsibilities\nAdhere to the Company’s quality management system processes and policies. \nComply with applicable regulatory requirements, policies, and procedures related to financial reporting transparency, Good Clinical Practice (GCP), and Good Documentation Practice (GDP).\nOther tasks as requested by the VP Clinical Development and Operations. \nEssential Skills, Qualifications, Industry and Educational Requirements\nStrong knowledge of clinical trial conduct, ICH-GCP guidelines, regulatory requirements, and the Sunshine Act.\nMeticulous attention to detail to ensure accuracy in documentation and financial tracking. \nDemonstrated ability to manage budgets, forecasting, and financial reconciliation. \nFlexibility to collaborate across different time zones\nExperience with TMF processes and inspection readiness standards. \nAbility to work to timelines and perform effectively in high-pressure environments. \nStrong organizational, analytical, and problem-solving skills. \nDesirable Skills, Qualifications, Industry and Educational Requirements\nProven track record in clinical operations delivery within a sponsor or CRO environment. \nDemonstrated expertise in vendor management, CRO oversight, and contract management. \nExperience with budgeting tools, CTMS, and eTMF systems. \nStrong communication and collaboration skills across cross-functional teams. \nMinimum 6-10 years’ experience in clinical operations (depending on level).\nBachelor’s degree in life sciences required; 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