BD (Becton, Dickinson and Company) Clinical Project Manager in Sydney, Australia
Job Description Summary
Working within the Global Clinical Development (GCD) organization, the Clinical Project Manager based in Australia is responsible for clinical trial management of multiple studies in Australia and New Zealand and may be a local subject matter expert for a group or platform of assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials conducted by GCD or Contract Research Organizations (CRO). The Clinical Project Manager may also serve as mentor to other local clinical team members. This role serves as the local project lead in Australia and New Zealand for studies of various complexity and supports protocol development through study conduct and closeout in compliance with Good Clinical Practices, and global, national and local regulations. The role reports to the International Portfolio Manager at GCD and collaborates with the respective global study Project Manager and Clinical Portfolio Manager to ensure an aligned planning and optimal trial execution.
Works with limited supervision and direction, prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
In collaboration with the global project management, ensures alignment on overall study timelines and deliverables and delivers accordingly for his/her region
Oversees/leads study-specific clinical resources, e.g. contractor CRA, CRO, etc.
Manages studies across business units
Mentors other clinical study team members as needed
Provides critical thinking and escalates accordingly when issues arise during execution of clinical studies.
Contributes to continuous improvement activities/initiatives
Manages relationships with sites/PIs and other study-related vendors, e.g. CROs
Functions as GCD contact person in the BD Australia/New Zealand organization
Has good knowledge of established project management standards to be able to plan and track regional study tasks accordingly (scope/work packages, time/schedule, cost/material and human resource, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions with the global project manager or other stakeholders as needed.
Defines, tracks and reports on project management schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff
Weighs in on resource and budget forecasts and timelines
Proactively identifies, escalates and manages risks and issues to ensure cost-effective timely delivery of the project
Maintains high quality standards in order to meet compliance requirements
All other duties as assigned.
Bachelor's degree required, preferably in the life sciences, clinical or other relevant technical areas
Minimum of 3 years project management experience
Minimum 5 years of clinical study experience, (e.g., pharmaceutical, medical device, IVD, biotechnology, CRO) including the proven ability to oversee clinical teams in the conduct and report of multicenter, global complex studies
Knowledge of clinical trial concepts and practices, including international clinical research guidelines and regulations
Strong client and vendor relationship management skills
Ability to work effectively, mostly independently in international teams, manage multiple projects and work in a fast paced and changing environment
Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences
Ability to work effectively in a virtual environment
Ability to travel approximately 30% of the time in Australia/New Zealand and internationally.
Primary Work Location
AUS Sydney - North Ryde
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.