Data Management Lead II (FSP), South Africa at PAREXEL

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