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. 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.
Responsibilities
Manage daily and weekly Data Management execution, including work assignment, staffing coverage, workload balancing, and team performance; Own daily plan adherence and weekly schedule attainment and escalate blockers before commitments are missed; Ensure first-pass quality, documentation completeness, data integrity, traceability, and reduction of avoidable rework; Coordinate handoffs with PM, PI, OM, QA, QC, SM, Finance, and IT/System Owners; Identify and escalate delivery, quality, compliance, data-integrity, system, and capacity risks; Apply and maintain approved procedures, templates, standards, KPIs, controls, and training requirements; Monitor and report Manager-level KPIs; Provide workload, backlog, staffing, and coverage data to functional leadership for 30-90 day capacity planning; Lead team-level process improvements and support automation and systems initiatives as an operational SME; Build team capability through coaching, onboarding, performance management, training, and engagement; Maintain compliant, audit-ready execution and support deviation, CAPA, change-control, and audit activities; Other duties as neededRequirements
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 such as 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; Strong analytical, problem-solving, written, and verbal communication skills; Proficiency with data-management platforms, reporting/analytics tools, Microsoft Office applications, and enterprise systemsNice to have
Advanced degree in life sciences, data science, information systems, business, or a related discipline; Experience leading data-management transformation, automation, systems implementation, validation, or operating-model redesign in a regulated environment; Experience with LIMS or similar laboratory systemsBenefits
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 ProgramHow to apply
Apply online: https://www.jobs.pl/en/oferta/101485825/aplikuj
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