Data Management Lead Job at Parexel

Job Description

We are hiring a remote based Data Manager Lead / Data Manager II to join our Parexel team. Location: Continental US. 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.

Job Responsibility

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

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

Parexel - All Job Offers

Select Country

Data Management Lead

Job Description

Job Responsibility

Requirements

Looking for more opportunities?