Data Management Lead I (FSP), multiple EMEA locations

The role can be based in multiple EMEA locations.

The Functional Service Provider (FSP) division of Parexel is seeking a candidate for DML II/DML 1 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