Data Management Lead II

1 month ago


REMOTE, Czech Republic Parexel Full time

Picture Yourself 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.

What You'll Do At Parexel:

Manage and coordinate the integration and utilization of all ancillary systems as appropriateHighlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management PlanReview and analyze metrics to derive meaningful summary of study health and trendsReview of the Master Services/Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance IndicatorsHost and attend cross-functional meetings. Prepare Meeting Agendas and Minutes, comply to action and decision logsPortray Parexel's technical and operational expertise and capabilities, and tailor to meet sponsor's specific needsCreate relevant slides with cross-functional Global Data Operations input as appropriateMaintain inspection-ready Trial Master FileIdentification of quality issues, ensuring they are raised in relevant system and closed according to requirementsPrepare for and participate in audits and inspections for internal, sponsor, and regulatory agenciesDrive 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 areaRegular review and update of DM resources to ensure alignment with contracted budget, project resource forecast, actuals, and demand, utilizing the necessary systems and toolsDetermine 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 EnglishProven data management experience in clinical research industry (CRO/Pharma)Proven record of leading project and program teamsStrong ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectivelyFull understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific proceduresAwareness of SDTM/CDISC/CDASH standardsStrong technical skills including, but not limited to the knowledge of Clinical Trial/DataManagement Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office productsStrong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approachProficient presentation skillsCustomer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trustProven problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses
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