Manager, Data Management

The Manager, Data Management will play a key role in building and leading a new Data Management function that supports laboratory and bioanalytical data within a CRO environment. This hands-on leader will manage the day-to-day details while establishing the processes, structure, and team needed to support the function as it grows. The Manager will hire, develop, and lead the Data Management team; oversee daily delivery, work assignment, schedule adherence, quality, coverage, training, and issue escalation; and partner closely with laboratory operations, project management, quality, and other cross-functional teams. This individual will resolve immediate blockers, manage delivery and compliance risks, improve processes, and support automation initiatives. Prior experience managing laboratory or bioanalytical data in a CRO environment is required.

Essential Responsibilities:

• Manage daily and weekly Data Management execution, including work assignment, staffing coverage, workload balancing, and team performance to support timely delivery.
• Own daily plan adherence and weekly schedule attainment; identify at-risk work, take recovery actions within authority, and escalate blockers before commitments are missed.
• Ensure first-pass quality, documentation completeness, data integrity, traceability, review readiness, and reduction of avoidable rework across assigned outputs.
• Coordinate handoffs with Project Management (PM), Principal Investigators (PI), Operations Management (OM), Quality Assurance (QA), Quality Control (QC), Sample Management (SM), Finance, and IT/System Owners so dependencies, acceptance criteria, and accountability are clear.
• Identify and escalate delivery, quality, compliance, data-integrity, system, and capacity risks within required timeframes; maintain clear blocker and action visibility.
• Apply and maintain approved procedures, templates, standards, KPIs, service expectations, controls, training requirements, and competency expectations within the assigned team.
• Monitor and report Manager-level KPIs, including daily plan adherence, weekly schedule attainment, first-pass quality, escalation timeliness, coverage reliability, and training completion.
• Provide workload, backlog, staffing, and coverage data to functional leadership to support 30-90 day capacity planning and bottleneck resolution.
• Lead team-level process improvements that reduce manual burden, rework, and cycle time; support automation and systems initiatives as an operational SME.
• Build team capability through coaching, onboarding, performance management, training, engagement, and identification of readiness for increased responsibility.
• Maintain compliant, audit-ready execution and consistent application of approved standards; support deviation, CAPA, change-control, and audit activities as applicable.

Additional Responsibilities:

• Other duties as needed

Minimum Preferred Qualifications: Education/Experience

• Bachelor’s degree in life sciences, health sciences, clinical research, business, or related field.
• 6 years of relevant CRO, laboratory, clinical, or data operations experience, including regulated data-delivery experience.
• 2-4 years of people-leadership experience in a regulated operations environment.

Minimum Preferred Qualifications: Skills

• Strong people leadership, daily/weekly work planning, workload prioritization, performance management, and team-development skills.
• Demonstrated ability to apply operating standards, KPIs, service levels, risk controls, and disciplined escalation processes.
• Strong knowledge of data integrity, traceability, data-lifecycle controls, quality principles, and regulated data-management expectations.
• Demonstrated familiarity with industry data standards and models for example SEND, CDISC, SDTM, ADaM.
• Ability to translate business needs into practical team-level process, reporting, technology, and automation improvements.
• Excellent cross-functional coordination and stakeholder-management skills, including the ability to clarify handoffs, resolve execution issues, and escalate appropriately.
• Strong analytical, problem-solving, written, and verbal communication skills, with the ability to present workload, delivery performance, and risk clearly to leadership.
• Proficiency with data-management platforms, reporting/analytics tools, Microsoft Office applications, and enterprise systems; experience with LIMS or similar laboratory systems preferred.

Preferred Credentials:

• Advanced degree in life sciences, data science, information systems, business, or a related discipline preferred.
• Experience leading data-management transformation, automation, systems implementation, validation, or operating-model redesign in a regulated environment preferred.

Supervisory Responsibility:

• Directly supervises individual contributors and/or frontline supervisors; responsible for staffing coverage, workload balancing, performance management, onboarding, training effectiveness, development, and team engagement.

Supervision Received:

• Works under limited supervision with responsibility for daily and weekly functional execution and team performance within established policies, standards, and priorities.
• Exercises independent judgment in work assignment, workload balancing, schedule recovery, immediate issue resolution, and timely escalation; escalates material cross-functional, capacity, quality/compliance, resource, or strategic decisions.

Position Type and Expected Hours of Work:

• This is a full-time, on-site position in our Durham, NC location
• Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work needed