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