Data Management Lead

Parexel•Southport, NC

2d•Remote

About The Position

The Data Manager Lead / Data Manager II provides technical expertise across all aspects of Data Management and serves as the primary Data Management point of contact for assigned studies. This role is responsible for ensuring contracted Data Management deliverables are met with a focus on quality and timeliness, while collaborating closely with cross-functional teams across global geographies. The successful candidate will manage study data delivery timelines, including Go-Live, Interim Deliveries, and Final Database Lock, while working with minimal guidance from Line Managers and/or Subject Matter Experts. The Data Manager II may also provide mentorship to Assistant Data Managers and Data Management peers.

Requirements

Strong ability to lead and collaborate with global teams across multiple time zones and cultures.
Strong negotiation and influencing skills.
Excellent interpersonal, written, and verbal communication skills.
Strong learning agility and knowledge-sharing mindset.
Flexibility and adaptability in changing environments.
Effective presentation skills.
Strong customer focus with the ability to build rapport and trust.
Commitment to quality with a methodical and accurate approach to work.
Strong time management and prioritization skills.
Proven problem-solving and root cause analysis capabilities.
Strong sense of ownership and accountability.
Ability to travel as required.
Written and spoken fluency in English.
Strong experience within the clinical research industry.
6+ years of hands on Clinical Data Management experience
Proven experience leading project and program teams.
Good understanding of project tools, reports, and processes related to project financial management, including forecasting, revenue recognition, scope of work, and departmental budgets.
Good understanding of Clinical Study Team roles outside of Data Management.
Strong knowledge and application of ICH-GCP guidelines, local regulatory requirements, Standard Operating Procedures, and study-specific procedures.
Awareness of SDTM, CDISC, and CDASH standards.
Strong technical proficiency with Clinical Trial/Data Management Systems such as InForm, Rave, Veeva, DataLabs, and Microsoft Office applications.
Bachelor’s degree and/or other qualifications in a science or clinical-related field.

Responsibilities

Manage study data delivery timelines, including Go-Live, Interim Deliveries, and Final Database Lock.
Collaborate with Clinical, Biostatistics, Database Programming, Medical, Medical Writing, and other cross-functional stakeholders across global regions.
Manage and coordinate the integration and utilization of ancillary systems, as appropriate.
Identify risks and issues impacting study delivery, define mitigation strategies, and drive issue resolution with stakeholders.
Review and analyze study metrics to identify trends and summarize study health.
Review Master Services Agreements, Service Level Agreements, and contracts to manage sponsor-specific metrics and Key Performance Indicators.
Attend cross-functional meetings and prepare agendas, meeting minutes, action logs, and decision logs.
Demonstrate technical and operational Data Management expertise and capabilities tailored to sponsor needs.
Provide input for bid pursuit presentations and materials.
Effectively represent the Data Management function as part of a cross-functional team during sponsor presentations.
Ensure compliance with Standard Operating Procedures and ICH/GCP guidelines.
Maintain inspection-ready Trial Master Files.
Identify and document quality issues, ensuring appropriate resolution and closure.
Prepare for and participate in internal, sponsor, and regulatory audits and inspections.
Drive and implement corrective and preventive actions and share lessons learned across projects and programs where appropriate.
Collaborate with Delivery Leads and line management to ensure appropriate project resourcing and staff assignments.
Identify and request functional resources required for project delivery.
Support the resolution of Data Management-related project variances, including scope changes where applicable.
Provide Data Management input to organizational initiatives.
Collaborate with cross-functional stakeholders to provide meaningful feedback on initiatives.
Ensure information maintained in management systems is accurate and up to date.
Maintain required training compliance, including on-the-job training.
Deliver project-specific training to internal Data Management teams.
Support identified development goals and training needs.
Provide on-the-job training when needed.