Director, Clinical Data Management (Clinical Data)

Location: Warren, NJ (hybrid); candidates local to the Warren area are strongly preferred, and applicants open to relocating to the area are welcome.

Salary: $200,700–$252,600 expected base salary annually, plus short- and long-term incentives. The listing also states $216,800–$260,000 plus bonus, stocks, and benefits.

Company

hirify.global is a pharmaceutical and biotechnology company developing therapies and managing clinical programs.

What you will do

• Provide strategic and operational leadership for clinical data management activities and teams.
• Lead clinical database development, EDC data cleaning, reconciliation, coding review, and database lock activities.
• Develop data management plans, data review plans, SOPs, working instructions, and quality documentation.
• Oversee CROs and external vendors, including clinical laboratories and data management partners.
• Collaborate with Clinical Operations, biostatistics, SAS programming, medical monitors, Legal, Compliance, and other functions.
• Support regulatory submissions, audits, inspections, clinical review, and validation of statistical outputs.

Requirements

• Bachelor’s degree in science, healthcare, or a related field.
• At least 10 years of progressively responsible experience in pharmaceutical, biotechnology, CRO, or regulatory agency environments.
• Proven leadership of clinical data management teams, including coaching and mentoring direct reports.
• Experience with clinical data technologies such as Medidata, Oracle RDC, InForm, Veeva EDC, IWRS, ePRO/eCOA, and relational databases.
• Knowledge of ICH, CDASH, CDISC, 21 CFR Part 11, FDA, EMEA, PMDA, GxP, GDPR, GAMP, and related regulatory requirements.
• Up to 25% travel and the ability to work effectively in a fast-paced, matrixed environment.

Nice to have

• At least five years of experience with Medidata RAVE, including EDC, R2DS/RBS, Architect, and Coder.
• Experience with PL/SQL, SAS, Java, C++, relational database design, and database programming.
• Experience applying risk-based approaches to process efficiency and compliance.

Culture & Benefits

• Flexible hybrid work model based in Warren, New Jersey.
• Short- and long-term incentive eligibility.
• Medical, dental, and vision plans.
• Retirement savings plans.
• Cross-functional collaboration with internal teams and external partners.