Data Management Lead II, based in Poland or Romania

Romania-Remote

Parexel

For over 35 years Parexel has been a trusted global CRO and biopharmaceutical services company. Learn more about how we can help.

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When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The role can be flexibly based in Poland or Romania.

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 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

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* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰

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Category: Leadership Jobs

Tags: Consulting Data management DataOps GCP Pharma Research

Regions: Remote/Anywhere Europe
Country: Romania

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