Associate Director, Data Management

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $169.2k - $253k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Act as a program-level data management expert and develop data management strategies • Identify and implement methodologies and technologies to support projects • Drive continual improvement and share lessons learned and best practices across projects and programs • Represent Clinical Data Management on program governance teams and joint operations committees • Manage scope, budget, and resources for assigned projects and programs • Develop and maintain SOPs and working practice documents for data management tasks • Identify risks and execute mitigation strategies • Maintain timely communication with management and cross-functional teams • Establish and manage data capture, management, and review standards for clinical research data quality and integrity • Provide consultation, leadership, and expertise to clinical development functions on data handling and management processes • Evaluate EDC and other data collection technologies • Participate in developing and maintaining standard eCRFs and edit specifications • Represent data management on key company initiatives • Manage external vendors and oversee deliverables • Participate in hiring, onboarding, mentoring, and training of data management staff • Line-manage direct reports and set performance expectations • Support the Director in leadership, direction, and operational management of the data management team

🎯 Requirements

• Demonstrated project management experience, including ability to work under tight timelines while balancing conflicting priorities • Management skills to accomplish work through others and maintain appropriate relationships • Experience working with and managing external service providers/vendors • Working knowledge of clinical trial data management processes and current regulations • Deep understanding of ICH GCP guidelines, CDASH standards, and applicable regulatory rules and guidelines • Strong organizational, time management, and resource-allocation skills • Ability to prioritize multiple tasks and programs with excellent attention to detail • Experience with regulatory audits and inspections • Excellent communication, interpersonal, and presentation skills • Experience providing oversight of CROs and external data vendors • Approximately 20% travel • Bachelor’s or Master’s degree (preferred) with a minimum of 10 years of clinical data management experience in the pharmaceutical industry

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Incentive opportunity