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Clinical Research Assoc III - United States  

Company managed [?] Still accepting applications

Posted on : 22 December 2017

Project Description

The primary role of the CSO Operational Capacity and Planning Manager (OPCM) is to act as the key CSO planning interface for the CSO Project Leader, the TMCP Lead (CSD from TMED platform), the Study Team and the Planning Project Manager (PPM) when customizing the clinical operational planning in the Planning, Resource and Cost management tool (Optime). He/she is also a strong interface with Capacity Management teams within CSO OPCM group and with Clinical Trial Finance team regarding clinical study key drivers and main planning impact. The OPCM is acting as the OPCM Leader for the clinical studies, coordinating activities from other OPCM entities (CS and TMED).  
 
Major Duties and Responsibilities:
 
  • Accountable of the customization and regular update of the activities/workpackages under his/her perimeter
  • Ensure the project strategy is reflected in terms of Planning into the operational plan in the customization horizon in consistency with resources and costs aspects
  • Play an OPCM Leader role for the clinical studies, coordinating activities from Clinical Supply and TMED (CSD and PK) OPCM teams (Operational impact management and PPM interface )
  • Analyze the project deliverable timelines and critical path activities
  • Communicates planning information across the Clinical Sciences & Operations platform and to any key IPOM OPCM interfaces or Regulatory OPM as needed
  • Identifies and anticipates any deviations, alerts key IPOM OPCM interfaces or Regulatory OPM in case of major events having an impact on project milestones and propose recommendations / facilitate decision making
  • Provide reporting and analysis to support the project team and operational teams, including during project meetings
  • Ensure a dedicated communication with the Capacity Management team within CSO OPCM group and Clinical Trial Finance (CTF) team in Finance.
  • Ensure history data follow-up in the planning tool and coordinate quality controls of planning data
  • Once agreed with Project actors, CSO OPCM is the single accountable person for the accuracy of the plan entered, its customization in the planning tool.
 
 
Required Education/Qualifications:
  • Minimum master in a scientific degree and/or at least 5 years of experience in Project Management/Planning
  • General knowledge on overall R&D Drug Development and good knowledge in Business operational activities (clinical trial execution)
  • General knowledge on Project Management methodology
  •  Strong knowledge in planning & management and tools
  • Analytical, synthesis and reporting skills
  • Excellent organizational skills, rigor, striving for results, high accuracy orientated
  • Strong communication skills and interpersonal relationship demonstrated
  • General knowledge in resources and capacity management
  • Excellent presentation skills (verbal and written)
  • Fluent in speaking English (verbal and writing)
  • Strong Networking skills