Senior Manager, Clinical Data Management

Job not on LinkedIn

🔥 3 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $164k - $200k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Lead data management activities for clinical studies or clinical programs • Serve as lead Clinical Data Management for multiple clinical trials • Ensure data quality and integrity for complex and/or pivotal clinical studies • Oversee activities outlined in the Data Management Plan • Develop data acquisition strategies • Ensure supporting systems are validated and meet intended study needs • Oversee outsourced Clinical Data Management vendors • Participate in vendor selection and management • 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 • Lead Clinical Data Management inspection activities • Manage inspection 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 • 8+ years of experience in Clinical Data Management • Effective communication, organizational, and project management skills • Knowledge of FDA/CFR and ICH/GCP • Familiarity with CDISC and CDASH standards • Experience leading complex or pivotal clinical trials preferred • Vendor oversight experience preferred • Inspection and audit support experience preferred

🏖️ Benefits

• Annual performance bonus • Long-term incentive plan • Medical insurance • Dental insurance • Vision insurance • 401(k) retirement plan with company match • Generous parental leave • Family planning benefits • Opportunities for personal and professional growth • Other incentive compensation plans (if applicable)

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