About Astellas
At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. 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. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
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.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver
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.
Essential Knowledge & Experience
· 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 follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
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.
Job Types: Full-time, Permanent
Work Location: Hybrid remote in Macquarie Park, NSW 2113
