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BioAgilytix

Global bioanalytical testing for drug development

Manager – Data Management

Data ManagementConfirmed live in the last 24 hours
Full-timeDurham, NC, USANo salary listed

About the Job

Requirements

  • A bachelor's degree in life sciences, health sciences, clinical research, business, or a related field is required.
  • At least 6 years of relevant CRO, laboratory, clinical, or data operations experience, including regulated data-delivery experience, is required.
  • At least 2 years of people-leadership experience in a regulated operations environment is required.
  • Strong people leadership, daily and weekly work planning, workload prioritization, performance management, and team-development skills are required.
  • Ability to apply operating standards, key performance indicators, service levels, risk controls, and disciplined escalation processes is required.
  • Knowledge of data integrity, traceability, data-lifecycle controls, quality principles, and regulated data-management expectations is required.
  • Familiarity with industry data standards and models, such as SEND, CDISC, SDTM, and ADaM, is required.
  • Ability to translate business needs into practical team-level process, reporting, technology, and automation improvements is required.
  • Cross-functional coordination and stakeholder-management skills are required, including the ability to clarify handoffs, resolve execution issues, and escalate appropriately.
  • Analytical and problem-solving skills and written and verbal communication skills are required, including the ability to present workload, delivery performance, and risk clearly to leadership.
  • Proficiency with data-management platforms, reporting and analytics tools, Microsoft Office applications, and enterprise systems is required.
  • The employee must be available during published core work hours; occasional weekend, holiday, and evening work is needed.

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, Principal Investigators, Operations Management, Quality Assurance, Quality Control, Sample Management, 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, key performance indicators, service expectations, controls, training requirements, and competency expectations within the assigned team.
  • Monitor and report Manager-level key performance indicators, 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 subject matter expert.
  • 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, corrective and preventive action, change-control, and audit activities as applicable.
  • Directly supervise individual contributors and/or frontline supervisors; manage staffing coverage, workload balancing, performance management, onboarding, training effectiveness, development, and team engagement.
  • Exercise independent judgment in work assignment, workload balancing, schedule recovery, immediate issue resolution, and timely escalation; escalate material cross-functional, capacity, quality/compliance, resource, or strategic decisions.
  • Perform other duties as needed.

Desired Qualifications

  • An advanced degree in life sciences, data science, information systems, business, or a related discipline is preferred.
  • Experience with LIMS or similar laboratory systems is preferred.
  • Experience leading data-management transformation, automation, systems implementation, validation, or operating-model redesign in a regulated environment is preferred.

About the Company

BioAgilytix

Global bioanalytical testing for drug development

BioAgilytix is a global bioanalytical laboratory offering testing services for pharma, biotech, and agricultural biotech. It specializes in large-molecule studies and provides PK/PD, cell-based, and immunogenicity assays to measure drug behavior and safety. Its services help clients develop and validate therapies and ensure product safety, including customizable COVID-19 testing packages. Its goal is to support drug and agricultural product development from research to regulatory approval by delivering precise, validated data.

Company size
501-1,000
Company stage
Growth Equity (Venture Capital)
Total funding
$30.1M
Headquarters
Durham, NC
Founded
2008

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