Clinical Study Planning Manager

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Job description

At ICON Clinical, within our Global Strategic Solutions Business Unit, as part of a global FSP Partnership with a leading pharmaceutical company, we are currently recruiting for an experienced Clinical Study Planning Manager.

Key Responsibilities:

• Lead the development of realistic study timelines, from design through final study reporting
• Maintaining accuracy of clinical study timeline information in data control systems (e.g., APECS)
• Tracking, documenting and ensuring key stakeholder involvement and timely delivery of clinical study deliverables
• Communicating information on clinical trial status, changes, and issues to stakeholders
• Increasing the efficiency of trial operations through the sharing of cross-program knowledge and identification of best practices leading to standardization across the organization
• Contributing to development of high performing study teams
• Participating in (or leading) special projects as assigned
• Adhering to all company policies, clinical development processes, SOPs, and clinical project management processes
• Represent CSP group in applicable forums and lead functional specific communications
• Manage the development of and monitor the implementation of high-quality, realistic, cross-functional, global clinical trial timelines in Company'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 (ie, via monthly RAP, annual LRP, quarterly LE, 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
• 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

Required Experience

• 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 Knowledge
• 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, PowerPoint) • Strong computer literacy, including word processing, presentation, and spreadsheet applications
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