Senior Clinical Study Manager

3 weeks ago

Sydney, New South Wales, Australia Pfizer Full time

Why Pfizer Needs You

Pfizer's medical team is seeking a skilled professional to manage clinical studies and oversee project management. As a Senior Clinical Study Manager, you will be responsible for planning, directing, and communicating timelines to ensure clinical studies are completed within time, budget, and scope.

Key Responsibilities

  • Develop and lead complex projects across business units and develop 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.

Requirements

  • Bachelor's Degree
  • 7+ years' experience
  • Applicable pharmaceutical industry experience
  • Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
  • Demonstrated project management/leadership experience
  • Experience with CRO oversight
  • Ability to evaluate, interpret, and present complex issues and data to support risk
  • Excellent communication skills, both written and verbal; must be fluent in English
  • Effective decision maker, analytical, and solution-oriented
  • Proficiency in Microsoft Office Suite

Preferred Qualifications

  • Master's degree
  • Broad-based experience in clinical research
  • Strong knowledge of Therapeutic Area, subject matter expertise, and international experience

About Pfizer

Pfizer is committed to the health and wellbeing of our colleagues and offers a range of great benefits, including paid parental leave, access to health and wellness apps, career growth experiences, recognition and rewards, paid volunteer days, life insurance benefits, and more.

Join Our Team

Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability, and through the Out Pfizer Employee Network (OPEN) for our LGBT+ colleagues and allies.

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