--- title: 'Manager, Data Management at BioAgilytix' canonical: 'https://feeny.ai/job/manager-data-management-bioagilytix-durham-pgc4tzgkexpj' type: 'job' last_seen: '2026-09-25' --- # Manager, Data Management at BioAgilytix - **Company:** BioAgilytix - **Location:** Durham, NC - **Work type:** onsite - **Posted:** 2026-09-21 - **Last confirmed live:** 2026-09-25 - **Apply:** https://jobs.lever.co/bioagilytix/763631b8-2f4e-499e-aa74-8e08f1a1de20 ## 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. 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 ## 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. To learn more about how we collect, use, and protect your information, please review our Privacy Policy and Terms of Use. ## About BioAgilytix ## Company Overview - **One-liner**: BioAgilytix is a global contract research organization providing GxP-compliant bioanalytical testing services to support pharmaceutical and biotech partners in all phases of drug development. - **Entity Type**: Private (funded) - **Headquarters**: Durham, North Carolina, United States - **Founded**: 2008 - **Founders**: Not publicly available ## Core Business - **Primary Industry**: Biotechnology Research / Bioanalytical Contract Research Organization (CRO) - **Target Customers**: B2B; specifically top pharmaceutical and biotechnology companies developing cutting-edge therapies. - **Mission or Purpose Statement**: To deliver innovative and reliable bioanalytical testing solutions, providing data and insight which lead to better, faster decisions on drug candidates in development. ## Products & Services BioAgilytix offers a comprehensive suite of laboratory services, primarily conducted under non-GLP, GLP, GCP, and GMP quality control testing: - **Pharmacokinetics (PK) Services**: Assay development, validation, and sample testing for small molecules, large molecules, and advanced drug modalities. - **Immunogenicity Services**: Screening, characterization, and neutralizing antibody assays to optimize drug safety, leveraging deep expertise in unwanted biotherapeutic-induced immunogenicity. - **Biomarker Analysis**: Fit-for-purpose biomarker assay development and testing from a menu of over 120 off-the-shelf assays, supporting clinical trial efficacy and safety. - **CMC Analytical Services**: Cell-based potency assays, molecular assays, mass spectrometry characterization, and other analytical methods supporting therapeutics from pre-IND to commercial release testing. - **Diagnostic Testing Services**: Offered at its CLIA-certified, CAP-accredited Boston laboratory. ## Market Standing - **Valuation/Market Cap**: Not disclosed (private company) - **Key Metric**: Annual Revenue of **$130M**; **$30.1M** in total funding from one prior round. - **Notable Investors/Partners**: Not specifically named in available sources. They support 21 of the world’s top 25 biopharma companies and supported ~30% of FDA-approved biologics from 2020 to 2024. - **Growth Signals**: - **1,100+ employees**, with a headcount growth of 2.1% YoY (+19 people) to 698 (according to LinkedIn, which may be lower than the company's self-reported total). - **Industry-leading employee retention rate of 90%**. - Global presence with labs in Durham, NC; Boston, MA; San Diego, CA; Hamburg, Germany; Melbourne and Brisbane, Australia; and partner labs in Beijing, China. ## Competitive Advantages - **World-Class Expertise**: Over 50% of scientists hold PhD and/or master’s degrees; the science team averages over 10 years of bench experience. - **Proven Track Record**: Supported ~30% of FDA-approved biologics between 2020 and 2024 and works with 21 of the top 25 global biopharma companies. - **Global Scale & Local Reach**: Operates in key biopharma hubs across the US, Europe, and Australia, with partner labs in China, enabling seamless global study transitions. - **High Retention**: A 90% employee retention rate indicates strong workplace satisfaction and internal stability. - **Comprehensive Capabilities**: Offers an "industry’s most complete set of capabilities," from assay development to commercial batch release, providing a consultative, scientist-to-scientist partnership model. ## Strategic Focus Based on available materials, BioAgilytix is focused on continued expansion of its global footprint (notably in Australia and Europe), deepening its expertise in advanced drug modalities (cell and gene therapies, oligonucleotides), and maintaining its leadership in bioanalysis for biologics. Its strategic focus is to proactively anticipate assay challenges to keep partner drug development timelines on track. ## Why Work Here - **Culture & Mission**: BioAgilytix fosters a culture of diversity, equity, and inclusion, supported by employee resource groups (ERGs). Employees solve "mission-critical bioanalytical solutions" that help bring therapies to patients faster. - **Work Policy**: Roles are **on-site** at specific lab locations (e.g., San Diego, CA; Melbourne, Australia; Durham, NC). This is a lab-based scientific organization. - **Benefits (US)**: Competitive compensation, health/dental/vision insurance, 401(k) savings plan, paid time off, paid parental leave, short- and long-term disability, group life insurance, employee assistance programs, adoption and fertility support, pet insurance, and legal assistance. - **Professional Development**: Access to high-visibility industry forums, continuous learning platforms, and opportunities to work on cutting-edge therapies for the world’s top pharma companies. ## Sources 1. [bioagilytix.com](https://www.bioagilytix.com/) 2. [bioagilytix.com - Careers](https://www.bioagilytix.com/about/careers/) 3. [bioagilytix.com - Corporate Brochure](https://www.bioagilytix.com/wp-content/uploads/2026/03/BioAgilytix-Corporate-Brochure-March-2026.pdf) 4. [linkedin.com](https://linkedin.com/company/bioagilytix) 5. [jobs.lever.co](https://jobs.lever.co/bioagilytix) ## Other roles at BioAgilytix - [Data Management Specialist](https://feeny.ai/job/data-management-specialist-bioagilytix-durham-rhpbfq2gbpsr) — Durham, NC - [Scientist III - LC/MS (Bioanalytical)](https://feeny.ai/job/scientist-iii-lc-ms-bioanalytical-bioagilytix-durham-e5tywmmffew1) — Durham, NC - [Scientist (Virology, 1 Year Fixed-Term )](https://feeny.ai/job/scientist-virology-1-year-fixed-term-bioagilytix-melbourne-waesgvzs03k5) — Melbourne, Australia - [Sample Reception Manager](https://feeny.ai/job/sample-reception-manager-bioagilytix-melbourne-mghjt6ebbehh) — Melbourne, Australia - [Project Manager / Senior Project Manager](https://feeny.ai/job/project-manager-senior-project-manager-bioagilytix-durham-mw9998bmgc7g) — Durham, NC - [Quality Engineer II](https://feeny.ai/job/quality-engineer-ii-bioagilytix-durham-wrbv8q6nqdpm) — Durham, NC - [Associate Director, Operations - GMP](https://feeny.ai/job/associate-director-operations-gmp-bioagilytix-durham-a2tjgck952a9) — Durham, NC - [Data Validation and Support Specialist](https://feeny.ai/job/data-validation-and-support-specialist-bioagilytix-melbourne-5afqwe2m7epc) — Melbourne, Australia - [Quality Assurance Associate](https://feeny.ai/job/quality-assurance-associate-bioagilytix-melbourne-8p4hvz9xnzkc) — Melbourne, Australia - [Director/Sr. Director, Business Development – Boston, MA](https://feeny.ai/job/director-sr-director-business-development-boston-ma-bioagilytix-boston-nkcerqt7sbhp) — Boston, MA