Clinical Study Outsourcing Manager

Job type:
on-site
Start:
ASAP
Duration:
18 months
From:
Harvey Nash IT Recruitment Belgium
Place:
Brabant Wallon
Date:
08/31/2013
Country:
flag_no Belgium
project ID:
592091

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Our client is a multinational pharmaceutical company located in Walloon Brabant and is currently looking for a Clinical Study Outsourcing Manager. The Clinical Study Outsourcing Manager will manage the selection and the performance monitoring of our clients suppliers (CRO).

Location: Walloon, Brabant

Duration: 18 months

Scope of work:

  • Accountable to train and support Clinical Functions in preparing, defining, tracking and managing their budget for Outsourced Clinical Studies within the agreed envelope and scope.
  • Lead the monitoring of the Clinical Expenses related to Outsourced Clinical Studies, proactively identify deviation from Budget and make sure actions are taken in order to spend the money on the most appropriate way.
  • Support CRO Selection.
  • Develop training and support Clinical functions in their planning and contract management process:
    • Establish and maintain processes and tools related to the set-up and monitoring of outsourced Clinical Studies budget management.
    • Creation of Cost per patient (CPP) template. Liaise with Clinical Development Managers (CDM) & Study Delivery Lead (SDL) in order to select the most appropriate procedures in the benchmarking tool.
    • Create the CPP proposal for each country and check consistency of figure provided.
    • Analysis of CRO's (Contract Research Organization) proposals in order to provide Clinical Operations team with information that will facilitate decision making & negotiation.
    • Approve exceptions to the standard procedure cost within the Business Operations range defined as per guidance.
    • Update of Benchmarking DB based on cost per procedure agreed with each CRO
    • Develop budgeting & expenses tracking processes
  • Consolidation and reporting of outsourced Clinical studies expenses
  • Ongoing cleaning of financial systems in order to have a clean view on Budget and expenses at the moment of Forecast
  • Interact with Clinical Senior Management to advice and ensure the best operational approach and ensure interface with other departments (Procurement, Legal, Finance and other Support department)
  • Develop good business practice & how to manage appropriate tracking of CRO.
  • Establish and maintain an internal benchmarking on Clinical Activities. Define a full study costing forecast model allowing to have a quick simulation of Future studies cost.
  • Develop with resources accountable person models to define workload related to clinical studies. (Internal or external development)
  • Develop KPI's related to Clinical studies outsourcing.

Requirements:

  • Advanced understanding of legal, financial and business processes.
  • Strong ability to network and negotiate at all levels in the organization and with outside partners.
  • Highly process oriented - able to write clear and comprehensive processes
  • Fluency in English is mandatory
  • Strong organizational skills
  • Mastering IT tools - Optimal use of IT systems and data management (Windows, SAP)
  • Degree in Sciences or Finance/Administration
  • At least 7 years' experience in a similar position at a pharmaceutical company or CRO
  • Knowledge of clinical development process & the management of clinical trials
  • Good communication skills. The job requires adequate management of interactions with very different parts of the organization (Internal & external clients, affiliates finance departments )
  • Analytical thinking (ability to understand & manage multiple and complex data, to recognize issues and proactively resolve or escalate as appropriate)
  • Strong analytical and problem solving skills
  • Customer oriented

Keywords: clincial study, clinical trial, outsourcing, CRO, CMO