Data Management Lead II (FSP) - South Africa, UK, Romania

Employer
Parexel FSP
Location
United Kingdom
Salary
Competitive
Start date
16 Jan 2023
Closing date
15 Feb 2023

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Discipline
Data Management / Statistics
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

The Functional Service Provider (FSP) division of Parexel is seeking a candidate for DML II role. The Data Management Lead ll provides leadership and expertise in all aspects of Data Management. Develop and manage timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management’s single point of contact to ensure that the contracted Data Management deliverables are being met - specifically in terms of timeliness, financial management and quality.

The Data Management Lead ll works with minimal guidance from their Line Manager and/or Subject Matter Experts. DMLs may act as a mentor for ADMLs or other DML peers. May act as Project Leader for projects involving only Global Data Operations services.

Main responsibilities:
  • Manage and coordinate the integration and utilization of all ancillary systems as appropriate
  • Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan
  • Review and analyze metrics to derive meaningful summary of study health and trends
  • Review of the Master Services/Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators
  • Host and attend cross-functional meetings. Prepare Meeting Agendas and Minutes, comply to action and decision logs
  • Portray Parexel's technical and operational expertise and capabilities, and tailor to meet sponsor's specific needs
  • Create relevant slides with cross-functional Global Data Operations input as appropriate
  • Maintain inspection-ready Trial Master File
  • Identification of quality issues, ensuring they are raised in relevant system and closed according to requirements
  • Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies
  • Drive and implement Corrective/Preventive actions for study, and work toward alignment across Parexel as appropriate - share lessons learned across multiple projects within a program or therapeutic area
  • Regular review and update of DM resources to ensure alignment with contracted budget, project resource forecast, actuals, and demand, utilizing the necessary systems and tools
  • Determine and resolve the root cause of DM-related project variance in a timely manner, including negotiating/raising changes in scope


Ideal candidate will possess:
  • Written and oral fluency in English
  • Strong experience in clinical research industry
  • Proven record of leading project and program teams
  • Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures
  • Awareness of SDTM/CDISC/CDASH standards
  • Strong technical skills including, but not limited to the knowledge of Clinical Trial/Data
  • Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products
  • Strong ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
  • Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
  • A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments
  • Proficient presentation skills
  • Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust
  • Proven problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses

Company

Parexel FSP provides biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies. We can offer a single expert or an entire department.

Our world-class network of experts helps to scale clinical trials, accelerate timelines, and maximize efficiency throughout development. We work every day to improve the world’s healths.

From clinical trial management to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do. We’re not just the people with brains, we’re the people With Heart®.

 

Find Us
Website
Mini-site
Parexel FSP
Location
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
GB
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