Manager, Data Management

Bioagilytix; Durham (NC); On-site; USD 110,000 - 155,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k with Employer Match

Paid Time Off

Job summary

BioAgilytix is seeking a Manager, Data Management to build and lead a new Data Management function within a CRO setting in Durham, NC. You will hire, develop, and guide the team, ensure data integrity, and manage delivery with cross-functional collaboration across PM, QA, IT, and Operations.

You will drive process improvements, establish KPIs, and manage risks while supporting automation initiatives and regulatory compliance in a fast-paced, client-facing environment.

Qualifications

• Bachelor’s degree in life sciences, health sciences, clinical research, business, or related field.
• 6+ years CRO, laboratory, clinical, or data operations experience in regulated environments.
• 2–4 years of people leadership in a regulated operations setting.
• Strong leadership, planning, workload prioritization, and team development.
• Knowledge of data integrity, traceability, data lifecycle controls, and quality principles.
• Familiarity with SEND, CDISC, SDTM, ADaM data standards.
• Ability to translate business needs into practical process/automation improvements.
• Experience with data-management platforms and LIMS or similar systems.

Responsibilities

• Manage daily/weekly Data Management execution, staffing coverage, and team performance to meet delivery.
• Maintain plan adherence, identify at-risk work, and recover to meet commitments.
• Ensure data quality, completeness, and traceability across outputs.
• Coordinate handoffs with PM, PI, QA, QC, IT, and other stakeholders.
• Identify and escalate delivery, quality, data integrity, and capacity risks.
• Apply approved procedures, KPIs, and training requirements within the team.
• Monitor and report KPIs and training completion for leadership.
• Provide data to support 30–90 day capacity planning and bottleneck resolution.
• Lead process improvements to reduce manual burden and enable automation.

Skills

People leadership

Planning

Data integrity

Cross-functional coordination

Problem solving

Regulatory data management

Communication

Education

Bachelor’s degree in life sciences/health sciences/clinical research/business or related field

Advanced degree preferred (life sciences, data science, information systems, business)

Tools

LIMS or laboratory systems

Reporting/analytics tools

Microsoft Office / enterprise systems

Job description

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

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.

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 escape 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 elevate 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

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

Benefits and Other Perks

• Medical Insurance (HDHP with HSA; PPO)
• Dental Insurance
• Vision Insurance
• Flexible Spending Account (medical; dependent care)
• Short Term Disability | Long Term Disability Life Insurance
• Paid Time Off (4 weeks per year)
• Parental Leave
• Paid Holidays (9 scheduled; 5 floating)
• 401k with Employer Match
• Employee Referral Program

Commitment to Equal Opportunity

BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

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