CLINICAL STUDY PLANNING MANAGER

Overview:

ICON is looking for a Clinical Study Planning Manager to Lead the development of realistic study timelines, from design through final study reporting.

Responsibilities:

• Manage the development of and monitor the implementation of high-quality, realistic, crossfunctional, global clinical trial timelines in Amgen’s planning systems within specified deadlines
• Conduct integrity checks and data issue resolution on a routine basis for assigned study timelines
• Manage, implement and communicate changes per the Change Impact Assessment Review & Approval (CIARA) process or other mechanisms as appropriate
• Ensure alignment of funding/investment of clinical studies within assigned programs to support operational planning by functions (i.e., via monthly RAP, annual LRS, quarterly LE, country/site allocations, etc.)
• Stay abreast of latest developments in drug development and contribute to advances in the practice of project management (continuous improvement)
• Maintain strong working relationships with study teams
• Collaborate on issues identification and resolution with study teams (e.g., identify bottlenecks)
• Ensure alignment with Integrated Project Plan (IPP)
• Inform management and stakeholders on status of and/or issues regarding program(s)/study timelines
• Compile program or study-related information for use with or deliver to internal or external groups
• Participate in (or lead) process improvement initiatives as assigned
• Monitor progress against study plans and against established process metrics
• Confirm acceptance of clinical study timelines with functional representatives ensuring alignment with key operational goals and timelines
• Create scenario options in support of decision-making for operational or strategic direction

Qualifications:

• Drug development knowledge with understanding of other functions, including Pre-Clinical, Clinical, Development Operations, and Regulatory
• Project management tools and processes (e.g., MS Project, PPM, PowerPoint, Excel)
• Strong computer literacy, including word processing, presentation, and spreadsheet applications

Basic Qualifications
• Doctorate degree
OR
• Master’s degree & 3 years of directly related experience
OR
• Bachelor’s degree & 5 years of directly related experience
OR
• Associate’s degree & 10 years of directly related experience
OR
• High school diploma / ED & 12 years of directly related experience
Preferred Qualifications
• BA/BS/BSc in the sciences or RN
• 5 years’ work experience in life sciences or medically related field, including 4 years of
biopharmaceutical clinical product development (clinical research or clinical operations
experience obtained at a biotech, pharmaceutical or CRO company)
• PMP Certification