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R and D - Clinical Data Standards Project Manager - Senior - Belgium   We are looking for an Senior R and D, Clinical Data Standards Project Manager

BrightOwl managed [?] Project on hold

Functional titles : Data Manager ,  Project Manager ,  Senior Clinical Project Manager (CPM) ,  R&D manager
Project Types : Permanent position ,
FTE : 100 %
Min.Experience : Senior
Start Date : ASAP
End Date : 31 Dec 2017
Posted on : 14 April 2017

Project is currently here

Step 1
Application
Step 2
BrightOwl Screening
Step 3
BrightOwl Interview
Step 4
Company Screening
Step 5
Company Interview
Step 6
Budgets & Contracts
Step 7
Position filled

Project Description

 

The Standards and Metadata project holds the following work streams:

  • Define.xml 2.0: On March 15, 2018, FDA will stop the support of define.xml 1.0. All trials started after that date need to be submitted with the CDISC define.xml 2.0 version. The objective of this work stream is to implement the capabilities required to deliver define.xml 2.0 in support of the SDTM and ADaM datasets submitted to the FDA. PMDA has very similar requirements.
  • Metadata Management: The objective of this work stream is to implement the capabilities required to manage standard and trial level metadata and to enable consumption of this metadata. In addition this work stream will need to deliver a new proprietary metadata model (incl. model definition, implementation and roll-out).
  • Data Conversion: The objective of this work stream is to implement the capabilities required to support data conversion from raw input data into several output formats (incl. SDTM).

 

This project needs to look at processes, technology and standards in support of the above work streams. On top these capabilities need to support the various sourcing models: in-house resourcing, functional outsourcing and strategic outsourcing.

 

Project Management responsibilities

  • Develop a comprehensive and complete project plan to meet the project deliverables and milestones
  • Execute successfully against the project plan

o Coordinate internal resources and third parties/vendors for the flawless execution of projects

o Coordinate and manage dependencies with other ongoing projects

o Coordinate and manage dependencies with drug development programs

o Coordinate and manage dependencies with new version of industry standards and guidelines

o Ensure that all deliverables are on-time, within scope and within budget

o Ensure resource availability and allocation

o Report progress against project plan

o Manage effectively changes in project scope, schedule and costs

o Measure project performance using appropriate systems, tools and techniques

o Report and escalate to management as needed

o Perform risk management to minimize project risks

o Create and maintain comprehensive project documentation

 

Project Management Requirements

  • Proven working experience as a project manager in the pharmaceutical industry, specifically clinical development
  • Solid background in clinical data management, biostatistics or statistical programming
  • Good understanding of the CDISC standards (CDASH, SDTM, ADaM, define.xml, Controlled terminology)
  • Excellent written and verbal communication skills
  • Solid organizational skills including attention to detail and multi-tasking skills
  • Strong working knowledge of Microsoft Office and Microsoft Project

 

 

 

 

 

 

Others

Project FTE 100%
Work from home:   Not Allowed
No. of Positions:   1

Personality

Communicative Organization Attention to detail

Knowledge

Clinical Data Management Biostatistics statistical programming CDISC CDASH SDTM ADaM define.xml

Skills and Expertise

data project management processes

Degree

Bachelor Master

Field of study

Pharmaceutical Sciences (Optional)

Languages

English
Professional Proficiency
Mandatory

Desired Skills & Experience

  • Solid background in clinical data management, biostatistics or statistical programming
  • Good understanding of the CDISC standards (CDASH, SDTM, ADaM, define.xml, Controlled terminology)
  • Excellent written and verbal communication skills
  • Solid organizational skills including attention to detail and multi-tasking skills
  • Strong working knowledge of Microsoft Office and Microsoft Project

What we offer

N.V.T.