Business Operations Manager, Site Contracting

Job Description

Business Operations Manager, Site Contracting Location: Australia Function/Business Area: Medical & Clinical Department: Clinical Operations Employment Class: Permanent Description Business Operations Manager, Site Contracting At Astellas, we offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science, and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team, or division. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness; and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit. The Opportunity: As a Business Operations Manager, Site Contracting, you will be responsible for the execution of assigned responsibilities within the relevant Clinical Operations support function for both early and late-stage Clinical Operations. You will manage and lead the day-to-day operations to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives. This role sits within Clinical Operations Excellence (COE). This position is based in Australia. Candidates interested in remote work are encouraged to apply. Responsibilities: Managing and possibly leading functional and cross-functional internal teams. Maintaining accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools, as well as proactively identifying and escalating issues that arise related to support functional deliverables. Providing Clinical Operations Vendor oversight/performance activities inclusive of vendor capability evaluation and selection, managing assigned vendors, planning/delivery of vendor governance meetings, analysis of key performance measures, vendor issue escalation, etc. Ensuring Clinical Operations (CO) Compliance related activities inclusive of holistic evaluation of CO related audit findings, execution of CAPA and process related effectiveness checks, and CO inspection readiness support. Supporting and implementing Study Start Up activities including global site and country level feasibility, site start up and activation, regulatory and ethics document preparation and submission. Extensive experience in pharmaceutical related drug development or direct equivalent. Demonstrable knowledge of clinical trial conduct, including multi-centre, global trials. Strong knowledge of ICH/GCP guidelines and regulatory requirements. Proven project management skills and leadership ability. Proficient in English and the primary language of the country of employment. Education/Qualifications: BA/BS degree life science or equivalent. Preferred Experience: Experience in working cross-functionally and with external providers. Experience with development and implementation of process improvement related initiatives. Additional Information: This is a permanent full-time position. This position is based in Australia. This position is 100% home/remote. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #J-18808-Ljbffr