Manager, Data Management

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.

Other duties as needed

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.

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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