Worldwide Clinical Trials
1001 - 5000 employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.
Associate Director, Operations – Clinical Assessment Technologies
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Worldwide Clinical Trials
1001 - 5000 employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.
📋 Description
• Identify operational needs for upcoming projects, track and review current assignments for CAT Operations staff • Resource CAT study projects as Resource Manager • Engage as Subject Matter Expert (SME) for CAT Operations activities • Provide operational oversight for designated CAT study projects • Engage in and coordinate resourcing activities for all CAT awarded projects • Identify training and skills gaps among staff; coordinate and assist with learning opportunities to enhance operations staff knowledge and skills of industry related regulations, processes, materials, and guidelines • Actively identify and engage in process improvement activities • Participate in QMD reviews and new QMD development • Author, collaborate, and review QMD documents and guidance documents • Coordinate and manage CAT Operations team meetings • Active engagement and oversight of study risk assessments, as they relate to operational activities • Work with department leaders to ensure alignment among CAT operational and clinical services • Lead and/or contribute to departmental initiatives that aim to implement polices, methods, techniques to contribute to existing service areas and department growth • Accountable for oversight of CAT study deliverables from Launch process to study close out • Assist and collaborate with Operations staff, Project Management, Contracts on vendor and study budget development, scope of work revisions, tracking and compliance • Assist in vendor management related concerns, including involvement with escalations, Vendor Management and Quality Assurance meetings • Review and assess ongoing budget utilization and revenue recognition with Operations Managers to ensure projects are meeting financial targets • Manage internal CAT operations meetings and other trial-specific meetings, as appropriate • Significant contributor to multiple strategic departmental, sponsor-related and cross-functional initiatives • Participate in business development activities including; but not limited to proposals input, capabilities, and bid defense meetings • Apply thorough knowledge of industry regulations and guidelines to ensure operational compliance during clinical trial conduct
🎯 Requirements
• Must have a minimum of a bachelor’s degree, preferably with an Master’s degree (life sciences, MBA and/or PMP certification). • Strong leadership, management and interpersonal skills • Strong planning and organizational skills • At least 7+ years clinical trial experience with at least 4 years’ experience in global clinical trials • Preferred at least 5+ years of experience managing team members or project management experience • Hands on experience in day-to-day management of all aspects of global clinical trials required • Prior experience in psychiatry / CNS therapeutic areas is a plus • Effective leadership skills and a proven ability to build and foster high performance team productivity and cohesiveness is required. • This position requires strong knowledge of monitoring practices, demonstrated knowledge / competence in the application of CFRs, GCPs and ICH guidelines.
🏖️ Benefits
• Health insurance • 401(k) matching • Flexible working hours • Paid time off • Professional development opportunities
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