Data Management Lead I

4 weeks ago

Homeworking UKHomeworking, UK, United Kingdom Parexel Full time
The role can be flexibly based in the U.

Picture Yourself At Parexel:

The Data Management Lead l provides leadership in all aspects of Data Management. Manages 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 l works under the guidance of their Line Manager and may receive additional direction/support from an experienced Data Management Lead or Subject Matter Experts. They may work as a co-DML with an experienced DML or work independently on less complex trials.

What You'll Do At Parexel:

  • 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
  • Proven data management experience in clinical research industry (CRO/Pharma)
  • Proven record of leading project and program teams
  • Strong ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
  • 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 interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
  • 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


#LI-REMOTE

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