Manager, Data Management

The Manager, Data Management leads the people, processes, and platforms that transform raw bioanalytical outputs into compliant, analysis-ready data packages for our clients. You will manage a high-performing team, shape data standards, own systems and workflows (including LIMS and SAS-based pipelines), and serve as a client-facing leader across complex, multi-site programs.ResponsibilitiesTeam Leadership & OperationsLead, coach, and develop a team of data managers, data reviewers, and analysts; set goals, conduct performance reviews, and build succession plans.Define and track operational KPIs (e.g., cycle time, first pass yield, query rate, on time delivery) and drive continuous improvement and automation.Forecast and allocate resources across studies; oversee vendor/contractor support as needed.Data Strategy, Standards & QualityOwn data management strategy for bioanalytical programs-from study start up through final deliverables-ensuring data integrity, traceability, and audit readiness.Establish, maintain, and enforce data standards, dictionaries, and controlled terminologies; harmonize across sites and platforms.Author/revise SOPs, work instructions, and data flow maps; lead deviation/CAPA investigations and risk assessments.Systems Ownership & Technical EnablementAdminister and optimize LIMS (e.g., Watson LIMS or equivalent), eCTD friendly export utilities, and data transformation tools.Oversee development, validation, and maintenance of SAS programs/macros and related pipelines; partner with IT/Validation on 21 CFR Part 11, GxP, ALCOA+ compliance and audit trail review.Champion interoperability and automation (APIs, ETL, templated exports, dashboarding/BI) to reduce manual handling and errors.Study Delivery & Client InterfaceServe as the primary data management contact for clients; lead data focused kickoffs, governance calls, and delivery reviews.Translate protocol and method requirements into executable data plans (metadata, naming, versioning, QC tiers, acceptance criteria).Oversee generation of validated data sets, reports, and transfer packages aligned to sponsor specifications and regulatory expectations.Inspection Readiness & ComplianceEnsure all data processes meet GLP, GCP (as applicable), and regional requirements; maintain inspection readiness.Lead/assist in client audits and regulatory inspections; coordinate responses and corrective actions.Skills, Education & QualificationsBachelor's degree in Life Sciences, Data/Computer Science, Engineering, or related field (Master's preferred).5-8+ years of data management experience in a CRO or regulated bioanalytical/analytical laboratory environment.2-4+ years of proven people leadership (managing teams or a department), including hiring, mentoring, and performance management.Expert working knowledge of SAS for data transformation, QC, and reporting; proficiency with LIMS.Strong command of GxP, 21 CFR Part 11, data integrity (ALCOA+), audit trails, and change control.Demonstrated client-facing experience: leading sponsor meetings, resolving data issues, and negotiating timelines/specifications.Excellent organization, communication, and stakeholder management skills across scientific, QA, and IT functions.The following additional Experience is a plus:Bioanalytical LC-MS/MS workflows; familiarity with pharmacokinetic data needs and common sponsor data specificationsExperience with Watson LIMS or similar platformsScripting/automation beyond SAS (e.g., Python/R, SQL, BI tools like Power BI/Tableau)Exposure to DSICS concepts (SDTM/ADaM awareness)Leading cross-site harmonization and system validation projects

Created: 2026-03-09