The Role
Oversee clinical trial operations, budgets, CRO and vendor relationships, contracts, invoices, change orders, purchase orders, and TMF quality. Partner with Finance, Legal, CMC, and preclinical teams to ensure trials meet timelines, budgets, GCP requirements, and quality standards. Monitor vendor performance, identify operational and financial risks, support inspection readiness, and train new team members on internal processes.
Summary Generated by Built In
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.
Key Responsibilities and Duties
- Develop, manage, and track site and study budgets in collaboration with CROs and internal Finance partners.
- Review, reconcile, and approve vendor and CRO invoices against contracts, milestones, and deliverables.
- Support clinical operations contracting processes, including review of scopes of work, vendor agreements, and amendments.
- Manage and review change orders, ensuring alignment with scope, timelines, and budget.
- Generate and maintain purchase orders (POs) in accordance with company processes and study budgets.
- Support vendor selection, onboarding, and ongoing performance management to ensure adherence to KPIs and contractual commitments.
- Support oversight of CROs to ensure clinical trials are executed according to timelines, quality standards, and contractual obligations.
- Conduct 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.
- Collaborate closely with cross-functional teams including Finance, Legal, CMC, Pre-clinical to ensure seamless execution of clinical programs.
- Proactively identify risks in study execution and financial management, and implement mitigation strategies.
- Support onboarding procedure and training on internal processes for new team members.
Responsibilities will include, but not limited to:
Other Responsibilities
- Adhere to the Company’s quality management system processes and policies.
- Comply with applicable regulatory requirements, policies, and procedures related to financial reporting transparency, Good Clinical Practice (GCP), and Good Documentation Practice (GDP).
- Other tasks as requested by the VP Clinical Development and Operations.
Essential Skills, Qualifications, Industry and Educational Requirements
- Strong knowledge of clinical trial conduct, ICH-GCP guidelines, regulatory requirements, and the Sunshine Act.
- Meticulous attention to detail to ensure accuracy in documentation and financial tracking.
- Demonstrated ability to manage budgets, forecasting, and financial reconciliation.
- Flexibility to collaborate across different time zones
- Experience with TMF processes and inspection readiness standards.
- Ability to work to timelines and perform effectively in high-pressure environments.
- Strong organizational, analytical, and problem-solving skills.
Desirable Skills, Qualifications, Industry and Educational Requirements
- Proven track record in clinical operations delivery within a sponsor or CRO environment.
- Demonstrated expertise in vendor management, CRO oversight, and contract management.
- Experience with budgeting tools, CTMS, and eTMF systems.
- Strong communication and collaboration skills across cross-functional teams.
- Minimum 6–10 years’ experience in clinical operations (depending on level).
- Bachelor’s degree in life sciences required; advanced degree (MSc or higher) preferred.
Skills Required
- Strong knowledge of clinical trial conduct
- Knowledge of ICH-GCP guidelines and regulatory requirements
- Knowledge of the Sunshine Act
- Experience managing budgets, forecasting, and financial reconciliation
- Experience with TMF processes and inspection readiness standards
- Strong organizational, analytical, and problem-solving skills
- Ability to work to timelines and perform effectively in high-pressure environments
- Proven clinical operations delivery experience within a sponsor or CRO environment
- Expertise in vendor management, CRO oversight, and contract management
- Experience with budgeting tools, CTMS, and eTMF systems
- Strong communication and cross-functional collaboration skills
- 6-10 years of clinical operations experience
- Bachelor's degree in life sciences
- Advanced degree such as an MSc or higher
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The Company
What We Do
AdvanCell is a clinical stage radiopharmaceutical company developing an innovative pipeline of 212Pb-based Targeted Alpha Therapies for cancer patients. AdvanCell’s platform technology addresses the most significant challenge in Targeted Alpha Therapy – the reliable and scalable supply of isotope. AdvanCell’s novel drug discovery, preclinical processes, and state-of-the-art facilities leverage daily access to 212Pb, the ideal isotope for Targeted Alpha Therapy. For more information, please visit www.advancell.com.au
