Data Management Lead Ii

3 weeks ago


Remote, United Kingdom Parexel Full time

The Data Management Lead ll works with mínimal 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
- Written and oral fluency in English
- Strong experience in clinical research industry
- Proven record of leading project and program teams
- 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

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