Data Management Lead II, based in Poland or Romania

Join Parexel's Mission to Improve Global Health as a Data Management Lead II

At Parexel, when our values align, there's no limit to what we can achieve. 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 a deep conviction in what we do.

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

About the Role

The Data Management Lead II (DML II) position can be flexibly based in Poland or Romania. In this role, you will work with minimal guidance from your Line Manager and/or Subject Matter Experts. You may also act as a mentor for ADMLs or other DML peers, and potentially lead projects involving only Global Data Operations services.

Key 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 summaries of study health and trends.
• Review 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, and comply with action and decision logs.
• Portray Parexel's technical and operational expertise and capabilities, and tailor them to meet sponsor-specific needs.
• Create relevant slides with cross-functional Global Data Operations input as appropriate.
• Maintain an inspection-ready Trial Master File.
• Identify quality issues, ensuring they are raised in the 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 studies, and work toward alignment across Parexel as appropriate. Share lessons learned across multiple projects within a program or therapeutic area.
• Regularly review and update DM resources to ensure alignment with contracted budget, project resource forecasts, 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 Profile

• Written and oral fluency in English.
• Proven data management experience in the 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-focused to interact professionally and respectfully within Parexel and with all external colleagues to build rapport and trust.
• Proven problem-solving skills, including the capability to make appropriate decisions in ambiguous situations and the ability to conduct root cause analyses.

Join Parexel and help us make a difference in improving global health.

Company Name: Parexel

Job Title: Data Management Lead II

Location: Poland or Romania