Clinical Study Manager
3 days ago
Pfizer Australia Pty Ltd is seeking a highly skilled and experienced Site Care Partner to join our team. As a key member of our medical operations team, you will play a critical role in ensuring the successful execution of clinical studies.
Why You'll Thrive in This RoleYou will be responsible for managing clinical studies, leveraging your project management skills to plan, direct, and communicate timelines. Your advanced knowledge of clinical research principles and concepts will enable you to lead complex projects across the division, developing and managing plans to achieve objectives and interpreting internal and external business challenges.
Key Responsibilities- Develop and lead complex projects across business units, developing plans to achieve objectives.
- Approve Study Startup, Study Monitoring, and protocol recruitment plans.
- Resolve escalated issues identified by the site activation subteam in partnership with the Study Manager.
- Work proactively with Clinical Research Organizations (CRO) and data management functions to ensure alignment on data flow and timely delivery.
- Manage Operational Study Management for one or more studies of limited complexity or a unique part of a larger study.
- Forecast and manage the Clinical Trial Budget for the program.
- Provide country and regional level input to country outreach surveys.
- Create awareness by working as a cross-functional Team Leader to deliver site intelligence initiatives with a variety of stakeholders, both internal and external.
- Approve and oversee drug supply management, manage flow of drug supply to the sites.
- Participate in global initiatives to improve operational efficiencies.
- Evaluate study progress reports and results for overall compliance and recommends corrective action or study termination for non-performance.
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
We're seeking a highly skilled and experienced professional with a Bachelor's Degree and 7+ years of experience in the pharmaceutical industry. You must have a working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations, and demonstrated project management/leadership experience. Additionally, you should have experience with CRO oversight, excellent communication skills, and the ability to evaluate, interpret, and present complex issues and data to support risk.
What We OfferPfizer Australia Pty Ltd offers a range of great benefits, including paid parental leave, access to Health & Wellness apps, Career Growth Experiences program, Recognition & rewards program, paid volunteer days, Life Insurance Benefits, Pfizer Learning Academy access to top content providers, access to flu vaccines & skin checks, options to purchase additional leave, and salary packaging & novated lease options.
We're committed to Diversity, Equity & Inclusion (DE&I) and offer engagement opportunities in Colleagues Resource Groups (CRGs) and workstreams across Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability, and the Out Pfizer Employee Network (OPEN) for our LGBT+ colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
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