Senior Manager, Technical Clinical Data Management

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Assume complete responsibility for the entire data management lifecycle activities for designated clinical trials.

• Act as the main Data Management Study Lead.

• Oversee timelines, facilitate cross-functional communication, manage risks, and ensure deliverables.

• Represent Data Management on the Clinical Study Team.

• Lead communications related to the study and manage expectations with the Data Management CRO.

• Supervise activities outlined in the Data Management Plan and ensure that deliverables meet quality and timeline standards.

• Utilize data intelligence to detect trends, enhance performance monitoring, and boost operational efficiency.

• Collaborate with IT to optimize external data transfers and integrate data across various systems.

• Manage outsourced clinical data management vendors and ensure their performance meets Deciphera's standards.

• Review vendor invoices as necessary.

• Work alongside cross-functional teams on data deliverables.

• Improve clinical data management processes and enhance collaboration across functions.

• Assist with departmental initiatives as required.

• Lead clinical data management inspection processes and address findings until resolution.

• Ensure that clinical data management documentation is thorough and properly filed in the Trial Master File.

• Perform additional duties and responsibilities as assigned.

⛳️ Requirements

• Bachelor's or master's degree with over 8 years of experience in Clinical Data Management.

• Understanding of FDA/CFR and ICH/GCP regulations.

• Familiarity with CDISC and CDASH standards.

• Experience with data visualization tools to create study-status and data quality dashboards.

• Proven ability to create and implement tools for clinical data workflows, including data review, automation, and visualization with proper validation and human oversight.

• Knowledge of AI technologies (e.g., Copilot, Claude).

• Strong communication, organizational, and project management skills.

• Experience with building in Medidata RAVE.

• Practical experience utilizing SAS for data extraction and validation.

• Familiarity with J-Review.

🏝️ Benefits

• Competitive salary and annual bonus.

• Comprehensive benefits package that includes medical, dental, and vision insurance, along with a 401(k) retirement plan featuring company match, and more.

• Generous parental leave and family planning benefits.

• Exceptional company culture and opportunities for both personal and professional development.

• Long-term incentive plan.

• Additional incentive compensation plans (if applicable).