Sr Manager, Clinical Data Management

Location: United States — Remote

Salary: $143,225–$185,350 per year, plus potential discretionary annual bonus, stock-based long-term incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing cancer immunotherapies, including CAR T-cell and TCR-engineered cell therapies.

What you will do

• Lead and oversee clinical data management deliverables for Kite-sponsored non-interventional studies, including post-marketing required studies and expanded access programs.
• Provide CDM expertise for collaborative and Investigator Sponsored Research studies and contribute to CDM strategy, processes, policies, SOPs, and continuous improvement.
• Coordinate with Clinical Operations, Medical Affairs, Translational Medicine, Safety, Biometrics, Clinical Development, Regulatory, Biostatistics, and other study teams.
• Oversee CRO and vendor activities, study timelines, data management documentation, eTMF completeness, regulatory readiness, and data integrity.
• Serve as a primary point of contact for internal and external study teams and lead CDM representation during internal and Health Authority audits.
• Manage, delegate, train, mentor, and potentially develop data managers and data management associates while communicating and escalating project-level issues.

Requirements

• High school degree and 12 years of experience, or a bachelor's degree and 8 years of experience, or a master's degree and 6 years of experience, or a PhD/PharmD.
• Proficiency with web-based electronic data capture systems such as Medidata Rave and other clinical data management systems.
• Experience with industry thesauri and dictionaries such as MedDRA and WHODD.
• Excellent verbal and written communication skills, including the ability to explain technical CDM topics to non-CDM staff.
• Project management skills, flexibility with changing priorities, attention to detail, ability to work under pressure, and willingness to take on unfamiliar tasks.
• Ability to prioritize and delegate study and initiative responsibilities and communicate or escalate issues involving processes, timelines, resourcing, and performance.

Nice to have

• Experience independently leading clinical data management deliverables for regulatory filings.
• Experience managing non-interventional studies in an oversight capacity.
• At least 10 years of relevant clinical-trial industry experience and a successful record of leading through influence across complex global organizational matrices.
• Experience with CDISC standards, including CDASH, SDTM, or ADaM.
• Strong knowledge of leading EDC tools such as Medidata Rave, Veeva EDC, Medrio EDC, Oracle, or TrialGrid, as well as emerging technologies supporting data collection.
• Experience interpreting Health Authority regulations and GCP/ICH guidelines, with a strong compliance background.
• Strong knowledge of pharmaceutical development and the ability to engage, manage, develop, and inspire geographically diverse teams.

Culture & Benefits

• Full-time remote position in the United States.
• Medical, dental, vision, and life insurance plans for eligible employees.
• Paid time off and potential discretionary annual bonus and stock-based long-term incentives.
• Inclusive environment focused on employee development, empowerment, diverse perspectives, and talent development.