Associate Director, Clinical Data Management (Clinical Data Standards)

Location: USA - New Jersey - Rahway; flexible work arrangements are not applicable. The role includes 10% travel and no relocation.

Salary: $142,400–$224,100 per year for the primary location; annual bonus and long-term incentive may apply.

Company

hirify.global is a pharmaceutical and healthcare company developing medicines and conducting global clinical research.

What you will do

• Provide program-level oversight of clinical data collection standards, library use, first-line governance, conformance, and benefits.
• Define and maintain EDC and non-EDC data collection standards aligned with CDISC, health-authority regulations, and the full clinical lifecycle.
• Lead Therapeutic Area Standards Teams, support information-governance reviews, and contribute to standards libraries, SOPs, work instructions, and business processes.
• Provide data collection, data transformation, and data-modeling oversight for therapeutic areas and assigned studies.
• Develop and deliver standards training, mentor Global Clinical Data Standards staff, and participate in industry forums.
• Support audits, inspections, study-team forums, cross-functional alignment, and continuous improvement initiatives.

Requirements

• Associate’s degree plus at least 15 years of clinical data management or standards experience, or bachelor’s degree plus at least 8 years, or advanced degree plus at least 4 years.
• Expertise in developing and implementing clinical data standards.
• Deep knowledge and experience applying CDISC clinical study data standards, including CDASH, Controlled Terminology, and SDTM.
• Deep understanding of clinical development trial processes, clinical data management, and worldwide regulatory data-management and reporting requirements.
• Knowledge of the drug discovery process, ICH, and GCP guidelines.
• Knowledge of at least one therapeutic area and ability to drive consistency across studies in a clinical development program or therapeutic area.
• Knowledge of analysis and reporting, electronic data capture, and external supplier data.
• Ability to take an enterprise-wide view covering Controlled Terminology, SDTM, analysis and reporting, submission targets, and deliverables.
• Ability to interpret study protocols and translate protocol requirements, data types, and data sources into compliant data-standard definitions.
• Strong communication, collaboration, organization, prioritization, influencing, stakeholder-management, judgment, mentoring, and continuous-improvement skills.

Nice to have

• Direct experience implementing Controlled Terminologies, CDISC CDASH, SDTM, ADaM, HL7, and analysis, reporting, and submission deliverables such as SDRG, ADRG, and Define.xml.
• Experience with eCRF design, clinical database development and validation, user acceptance testing, external data management, SDTM data transformation, analysis, and reporting.
• Ability to use technical solutions to manage functional or project deliverables and associated quality.

Culture & Benefits

• Inclusive environment that values diverse experiences, perspectives, skills, and backgrounds.
• 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.
• Regular employee status with annual bonus and long-term incentive eligibility where applicable.