Senior Manager, Clinical Data Management & Strategy

Regulatory Jobs; United States; Remote; USD 164,000 - 200,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

Benefits package

Parental leave

Job summary

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is seeking an experienced Senior Manager, Technical Clinical Data Management to take full accountability for end-to-end data management lifecycle activities across assigned clinical trials.

In this dual-function role, the individual will serve as the primary Data Management Study Lead, managing timelines, cross-functional communication, risks, and deliverables while also applying hands-on technical expertise.

Qualifications

• Bachelor's or master's degree with 8+ years of experience in Clinical Data Management.
• Knowledge of FDA CFR and ICH/GCP.
• Familiarity with CDISC and CDASH standards.
• Experience with data visualization tools to build study-status and data quality dashboards.
• Experience creating and applying tools to clinical data workflows, including data review, automation, and visualization with appropriate validation and human oversight.
• Familiarity with AI (e.g. Copilot, Claude).
• Effective communication, organizational, and project management skills.

Responsibilities

• Represent Data Management on the Clinical Study Team, lead study communications, and manage expectations with the Data Management CRO.
• Oversee all activities defined in the Data Management Plan (DMP) and ensure study deliverables meet quality and timeline expectations.
• Advance vendor oversight by applying data intelligence to identify trends, strengthen performance monitoring, and improve operational efficiency.
• Partner with IT to streamline external data transfers and integrate data across systems for cross-functional use.
• Oversee outsourced CDM vendors and ensure performance aligns with Deciphera standards.
• Review vendor invoices as applicable.
• Collaborate with cross functional team on data deliverables.
• Enhance CDM processes and strengthen cross functional collaboration.
• Lead CDM inspection activities and manage findings to resolution.
• Ensure CDM documentation is complete and filed in the TMF.

Skills

CDM leadership

Data management

Vendor management

Cross-functional collaboration

Project management

Communication skills

AI familiarity

Education

Bachelor's or Master's degree in Life Sciences

Tools

Medidata RAVE

SAS

J-Review

Job description

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is seeking an experienced Senior Manager, Technical Clinical Data Management to take full accountability for end-to-end data management lifecycle activities across assigned clinical trials.

In this dual-function role, the individual will serve as the primary Data Management Study Lead, managing timelines, cross-functional communication, risks, and deliverables while also applying hands-on technical expertise.