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- Data Management Lead II (FSP) - UK, Ireland, Romania
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Data Management Lead II (FSP) - UK, Ireland, Romania
Parexel International Corporation
Multiple Locations
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
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Job posted: 2022-09-07