Senior Clinical Study Manager

3 weeks ago


Sydney, New South Wales, Australia Pfizer Full time

Why Patients Need You

Pfizer's medical team is seeking a skilled professional to manage clinical studies and leverage project management skills for planning, directing, creating, and communicating timelines. The ideal candidate will ensure that clinical studies are completed within time, budget, and scope.

What You Will Achieve

As a Senior Manager, you will lead complex projects across the division, develop and manage plans to achieve objectives, and interpret internal and external business challenges. Your ability to develop and manage plans will facilitate in achieving objectives, and your problem-solving ability and patience will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Develop ideas, lead/co-lead complex projects across business units, and develop plans to achieve objectives.
  • Approve the 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.

Qualifications

Must-Have

  • 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

Nice-to-Have

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

At Pfizer, we care about our colleagues' wellbeing and offer a range of great benefits for them, 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
  • Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.

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.

If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.



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