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Job Details

Data Management Lead

Company: PAREXEL
Location: Romania
Reference: 49982BR
Closing Date: 18 Feb 19
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

The Data Management Lead provides leadership and expertise in all aspects of Data Management and Clinical Data and Database Programming. The Data Management Lead manages the delivery of all relevant data operations activities from database setup through database lock and data transfers. ...

Requirements:

The Data Management Lead provides leadership and expertise in all aspects of Data Management and Clinical Data and Database Programming. The Data Management Lead manages the delivery of all relevant data operations activities from database setup through database lock and data transfers.
General areas of responsibility include: coordination of the relevant Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact to ensure that the contracted data deliverables are being met – specifically in terms of timeliness, financial management and quality.
May act as Project Leader for projects involving a small number of services, where no Project
Leader is assigned.

Key Accountabilities

  • Provide leadership to ensure the project or program is completed within budget, schedule and according to contract specifications. Ensure the project/program is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfill regulations (including oversight and maintenance of relevant data operations project documentation).
  • Thorough knowledge of numerous EDC systems (DataLabs, InForm, Rave.)
  • Thorough knowledge of the eClinicalsuite and additional tools and systems that can be integrated with a particular EDC system ( MyTrials, IVRS etc ) and Reporting functionality within the EDC system )
  • Thorough knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation.
  • Thorough knowledge of all activities during Study Maintenance and Database Lock. Review of metrics to determine risks and risk mitigation plans as required.
  • Effectively communicate to and manage internal project teams, external customers and third party vendors.
  • Effectively manage contracted project delivery. Highlight issues/risks to delivery and mitigate risks for both PAREXEL and the client, developing contingency plans for the project (or providing input to PL). Accountable for quality control of project deliverables and timely delivery of projects.
  • Ensure information entered into management systems is accurate and updated on a regular basis.
  • Review metrics reports regularly, determine the cause of any project overruns, track scope of ongoing work to identify and raise CIS in a timely manner.
  • Participate in cross functional meetings and drive initiatives, participate in Business Development and BID Defense meetings as required.
  • Prepare, participate in and follow up on audits/inspections.

QualificationsSkills:
  • Leadership skills that include:
    • Building and leading global (virtual) teams
    • Ability to work effectively with and motivate virtual teams
    • Ability to negotiate and influence in order to achieve mutually beneficial results
    • Proven problem solving skills
    • Strong communication skills with a diplomatic approach
    • Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail
  • Personal skills that include:
    • Excellent interpersonal, oral and written communication skills
    • Ability to gain trust and confidence with a variety of clients as well as within PAREXEL
    • Excellent learning ability
    • Managerial courage, resilience, and ability to adjust to a rapidly changing environment
    • Excellent presentation skills
    • Ability to travel as required

Knowledge and Experience:
  • Substantial experience in clinical research.
  • Proven record of leading project and program teams in a technical/programming or data processing environment.
  • Strong understanding of cross functional activities.
  • Strong customer service focus.
  • Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and study specific procedures.

Education:
  • Bachelor’s degree and / or other qualifications in a science or industry related discipline.
  • Competent in written and oral English.

Skills:
  • Leadership skills that include:
    • Building and leading global (virtual) teams
    • Ability to work effectively with and motivate virtual teams
    • Ability to negotiate and influence in order to achieve mutually beneficial results
    • Proven problem solving skills
    • Strong communication skills with a diplomatic approach
    • Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail
  • Personal skills that include:
    • Excellent interpersonal, oral and written communication skills
    • Ability to gain trust and confidence with a variety of clients as well as within PAREXEL
    • Excellent learning ability
    • Managerial courage, resilience, and ability to adjust to a rapidly changing environment
    • Excellent presentation skills
    • Ability to travel as required

Knowledge and Experience:
  • Substantial experience in clinical research.
  • Proven record of leading project and program teams in a technical/programming or data processing environment.
  • Strong understanding of cross functional activities.
  • Strong customer service focus.
  • Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and study specific procedures.

Education:
  • Bachelor’s degree and / or other qualifications in a science or industry related discipline.
  • Competent in written and oral English.

Apply for this job: Data Management Lead

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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