Quanticate UK - Head Office

Project Data Manager

UK-Hertfordshire-Hitchin | UK-Home Based
2 weeks ago(1/4/2018 4:59 AM)
ID
2018-1670
# of Openings
1
Category
Data Management

Overview

An exciting opportunity has arisen for a Senior Project Data Manager within our Clinical Research Organisation (CRO), Quanticate. You will provide Project Management oversight to the data processing team to ensure the completion of Data Management projects according to sponsor and contract requirements and in accordance with applicable standard operating procedures. This will involve effective management of all data management aspects of assigned projects, from set up to database lock, from an operational and financial standpoint.

 

This role offers great flexibility with the option to be home or office (Hitchin, Hertfordshire) based.

Responsibilities

As a Senior Project Data Manager you will be expected to:

 

  • Act as the primary data management contact, both external and internal, for Quanticate projects
  • Ensure launch, delivery and completion of all Data Management procedures according to contractual agreement and relevant SOPs, guidelines and regulations
  • Monitor and communicate project progress to the customer and project team, including use of project status reports, and tracking tools/metrics
  • Manage changes of scope, budget, revenue recognition, and participation in internal project reviews.
  • The building of quotes and proposals in response to RFPs
  • Ensure consistency of process and quality across projects
  • Manage work assignment and delivery of project tasks to the off-shore data processing and programming team as required
  • Line management responsibilities for any assigned direct reports, including professional development/training and performance appraisals
  • Be prepared to represent Quanticate at bid-defence meetings and conferences as required
  • Be willing to travel both domestically and internationally as necessary
  • To undertake other ad hoc tasks as required

Qualifications

In order to be considered for this role, you will demonstrate the following key skills and attributes:

 

  • Bachelor’s degree, nursing qualification or equivalent level of experience (in life sciences or related subject)
  • Extensive experience in the pharmaceutical industry, including time in a CRO environment, with a proven track record of Data Management, working with clinical information and clinical development processes
  • Line and project management experience, ideally including staff in multiple regions
  • Demonstrated strong track record of leading studies through the data management life cycle in a customer facing role
  • Software Competence: MS Office, MS Project, Outlook, knowledge of project management software
  • Strong experience with Clinical Data Management practices and relational database management software systems Direct exposure to Oracle Clinical RDC, RAVE, or Inform systems
  • Excellent written and oral communication skills
  • Requires strong attention to detail and the ability to establish priorities, schedule and meet deadlines
  • Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands
  • Knowledge of medical terminology, clinical data, and applicable regulatory rules and guidelines: e.g. ICH, GCP, essential
  • Experience with financial budgeting & forecasting
  • Good problem and conflict resolution skills

 

The Clinical Data Management Department

 

With approximately 27 Individuals spread across our UK and India offices, the Clinical Data Management (CDM) Department continues to expand, inclusive of CDM Programming and Medical Coding roles. The team reports to our Vice President, Head of Clinical Data Management, based in the UK, with Operational and Governance oversight roles managed regionally.

 

Line managers are responsible for each individual’s development and performance, including objective setting, mentoring and support. Operational teams will also work under the guidance of a Project Data Manager who will ensure that we are delivering projects on time, to budget and to the required quality standard while applying Quanticate Project Management Principles.

 

Summary

 

This is a fantastic opportunity to develop a career in clinical data management within a CRO that specialises in data-related services. As a key member of a small team, your contribution to studies will be integral in forming key study-related decisions, and you will be hands-on from an early stage, working on numerous studies for large clients. You will receive substantial training and guidance that will enable you to gain a clear appreciation and understanding of clinical trial reporting, from data collection through to regulatory submission.

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