Senior Manager, Technical Clinical Data Management

Job not on LinkedIn

🔥 1 hour ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $164k - $200k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Deciphera Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.

📋 Description

• Take full accountability for end-to-end data management lifecycle activities across assigned clinical trials • Serve as the primary Data Management Study Lead • Manage timelines, cross-functional communication, risks, and deliverables • Represent Data Management on the Clinical Study Team • Lead study communications and manage expectations with the Data Management CRO • Oversee activities defined in the Data Management Plan and ensure deliverables meet quality and timeline expectations • Apply 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 • Oversee outsourced clinical data management vendors and ensure performance aligns with Deciphera standards • Review vendor invoices as applicable • Collaborate with cross-functional teams on data deliverables • Enhance clinical data management processes and strengthen cross-functional collaboration • Support department initiatives as needed • Lead clinical data management inspection activities and manage findings to resolution • Ensure clinical data management documentation is complete and filed in the Trial Master File • Perform other duties and responsibilities as assigned

🎯 Requirements

• 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 • Experience building in Medidata RAVE • Hands-on experience using SAS for data extraction and validation • Experience with J-Review

🏖️ Benefits

• Competitive salary and annual bonus • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more • Generous parental leave and family planning benefits • Outstanding culture and opportunities for personal and professional growth • Long-term incentive plan • Other incentive compensation plans (if applicable)

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