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.
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:
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.
