Sr Mgr Clinical Data Mgmt

Position Overview

Senior Manager Clinical Data Management – Hoboken, NJ (Onsite 3 days). Base salary range of $160k - $180k (depending on experience) with 20% bonus, stock options, full benefits, and full relocation assistance available if needed.

This role requires a minimum of 3 days a week onsite presence in one of our offices (Jersey City, New Jersey; New York, New York; or Millbrae, California) to ensure effective management, operational excellence, and high‑performance delivery of clinical studies, while supporting significant team growth and collaboration.

You are a driven individual who focuses on detail, an expert in data management, and a strong collaborator.

• Provide clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects.
• Plan, coordinate, and deliver complete, high‑quality and reliable clinical trial data in a timely manner for assigned projects.
• Serve as the primary point of contact for internal and external study team members for end‑to‑end data management activities.
• Provide strong quality and project oversight over third‑party vendors responsible for data management deliverables.
• Lead on gathering content and integration requirements for EDC and collaborate with partners supporting other data collection systems (eCOA, External Data, RTSM).
• Enforce data standard conventions and quality expectations for clinical data per defined processes.
• Author, review, and revise DM‑related study plans, including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines, and other study documents.
• Chair Data Review meetings with cross‑functional study team members to ensure ongoing review of trial data currency, quality, and completeness.
• Represent DM on cross‑functional project teams and submission teams.
• Lead or support Health Authority inspections and audits.
• Provide coaching and quality oversight of junior Data Management Leads.
• Act as a core member of the study team and provide FSP/CRO/vendor oversight for end‑to‑end data management activities, manage data currency throughout the trial, and monitor DM deliverables according to the Service Level Agreement.
• Provide relevant support to set up and validate the standard eCRF library.

• Post‑graduate degree with 6+ years of experience, or a bachelor’s degree with 8+ years of experience in Life Sciences, Biostatistics, Computer Science, or a related discipline.
• Proven experience in clinical data management from recognized suppliers/vendors, reputable CROs, or sponsor environments working on multi‑phase, multi‑therapeutic, and diverse clinical trials from initiation to completion, including regulatory submission and inspection preparation.
• Oncology experience required.
• Ability to collaborate on multidisciplinary project teams and develop productive relationships with external vendors.
• Sound knowledge of the Clinical Drug Development Process, FDA/ICH guidelines, and industry‑standard data‑management practices.
• Strong knowledge and experience of EDC systems (Veeva CDMS preferred) and Microsoft Office tools, as well as emerging technologies supporting data collection.
• Strong project‑management skills with expertise in metrics analysis and reporting methodologies.
• Excellent oral and written communication skills, with the ability to communicate effectively with senior management and cross‑functional teams.
• Deep knowledge of CDASH/CDISC (CDASH CRF Library implementation experience preferred).
• Knowledge of submission requirements, e.g., NDA/BLA/MAA.

• Bonus and equity compensation.
• 401(k) plan with company matching.
• Medical, dental, and vision insurance with premiums covered at 95%–100% (medicines covered at 100%).
• Mental health and wellness benefits.
• Weeklong summer and winter holiday shutdowns.
• Generous paid time off and holiday policies.
• Life/AD&D insurance with premiums covered at 100%, and optional supplemental employee‑paid life/AD&D policies.
• Enhanced parental leave benefit.
• Daily subsidized lunch program when on‑site.

Please contact Darren Gutowski at  for more information.