Senior Director, Clinical Data Management (Clinical Data Management)

Location: Hybrid; primary location in North Wales, Pennsylvania, United States. No relocation. Travel requirements: 10%.

Base salary: $173,200–$272,600 per year, with annual bonus and long-term incentive eligibility where applicable.

Company

hirify.global is a pharmaceutical and life sciences company developing medicines and conducting global clinical development programs.

What you will do

• Set strategy and oversee standards delivery, governance, operations, resource planning, process excellence, innovation, and enterprise metrics for global clinical data standards.
• Guide teams in defining and maintaining EDC and non-EDC data collection standards aligned with CDISC, health authority regulations, and submission requirements.
• Oversee standards governance deliverables, libraries, implementation plans, training, best practices, and future processes and tools.
• Lead cross-functional strategic projects, governance forums, stakeholder networks, audits, inspections, and escalation management across clinical development and data management functions.
• Provide strategic direction for data collection, data transformation, data modeling, study-level design, and application of standards across multiple therapeutic areas.
• Manage people, recruiting, performance, career development, budgets, resource models, workload balancing, and leadership communications.

Requirements

• Bachelor’s degree and at least 13 years of experience in Clinical Data Management or a related discipline, including 3 years in clinical data standards development or metadata management and at least 5 years of direct or matrix people management; or an advanced degree and at least 10 years of relevant experience, including the same 3 years in standards development or metadata management and 5 years of people management.
• Deep subject-matter expertise in clinical information standards and clinical data standards development and implementation.
• Deep knowledge of Controlled Terminologies, CDISC, CDASH, SDTM, ADaM, HL7, and analysis, reporting, and submission deliverables including SDRG, ADRG, and Define.xml.
• Deep understanding of clinical development trial processes, clinical data management, and worldwide regulatory data management and reporting requirements.
• Understanding of program-level clinical and business requirements, the Drug Discovery Process, ICH, and GCP guidelines.
• Advanced knowledge across more than two therapeutic areas and the ability to drive consistency across studies and clinical development programs.
• Experience with electronic data capture, external supplier data, study protocol interpretation, study design, data types and sources, and compliant data standard definitions.
• Strategic leadership, stakeholder management, negotiation, communication, collaboration, decision-making, change leadership, continuous improvement, and operational excellence skills.
• Ability to lead geographically diverse cross-functional teams, manage escalations, drive consensus, recruit and retain talent, and plan FTE, contingent, onshore, and offshore resources.

Nice to have

• ACRP Certified Professional membership or certification.
• Experience with eCRF design, clinical database development and validation, user acceptance testing, external data management, data extraction, SDTM transformation, analysis, and reporting.
• PMP certification or project management experience.
• Knowledge of clinical data metadata, information management principles, new technologies, and regulatory submission requirements.
• Knowledge of FAIR and ALCOA principles and their application to information management and stewardship.
• Ability to use technical solutions, programming, and other applications to manage deliverables, quality, and data insights.

Culture & Benefits

• Hybrid work arrangement with first-shift daytime hours.
• Medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits including a 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Inclusive environment focused on diverse perspectives, respectful challenge, collaboration, psychological safety, and talent development.

Hiring process

• Applications are submitted through the hirify.global careers site.
• Accommodation support is available during the application and hiring process.