Manager, Data Management

BioAgilytix•Durham, NC

1d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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.

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.
Other duties as needed