Precision Medicine Group
1001 - 5000 employees
Founded 2012
💼 Consulting
🏥 Healthcare
📦 Logistics
💰 $35.2M Venture Round on 2021-03
Consulting • Healthcare • Logistics
Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.
Director, Site Start-up
🔥 7 minutes ago
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Precision Medicine Group
1001 - 5000 employees
Founded 2012
💼 Consulting
🏥 Healthcare
📦 Logistics
💰 $35.2M Venture Round on 2021-03
Consulting • Healthcare • Logistics
Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.
📋 Description
• Provide leadership, guidance, and overall support to the Site Start-up team across project delivery, communication, human resources, revenue enhancement, procedures, systems, and processes • Support management of site start-up delivery through direct management and cross-functional oversight of IRB/EC submissions, Competent Authority submissions, governing organizations, site contracts, budget negotiations, and other start-up requirements • Establish the Precision for Medicine Site Start-up framework with the Head of Site Start Up, including intelligence, tools, methodology, risk evaluations, and mitigations • Collaborate with Clinical Operations, project management, and other cross-functional departments on global and regional Site Start-up planning, execution, and governance • Support corporate and departmental business strategies and act as an ambassador for change management during global growth and expansion • Provide leadership and oversight for large and increasingly complex Site Start-up programs • Manage escalations and remediate Site Start-up concerns • Optimize processes and delivery to meet or exceed budget targets and improve team profitability • Partner with Global Resourcing on assessment and management of Site Start-up leads, specialists, and Site Contract Management staff • Support career development, growth, and succession planning for the Site Start-up team • Coordinate Site Start-up Lead participation in client meetings and presentations • Collaborate with Business Development on opportunities, proposals, budgeting, bid defense preparation, and attendance • Support project strategy, evaluations, required changes, KPI reporting, and continuous improvement • Reinforce company culture and values to motivate, engage, and retain the Site Start-up team • Ensure clinical trials comply with local and regional regulatory requirements, ICH Guidelines, Good Clinical Practices, and SOPs
🎯 Requirements
• Bachelor's degree in life sciences or a related field, or equivalent combination of education, training, and experience • Minimum 12 years of clinical research experience, including extensive Site Start-up experience • Experience working for a Clinical Research Organisation (CRO) • Experience in people management • Expert knowledge of GCP/ICH guidelines and the clinical development process • Demonstrated leadership track record • Experience working in a team environment with resource management experience • Experience with Microsoft Office products: Outlook, Word, Excel, and PowerPoint • Clinical software experience, including CTMS, eTMF, and EDC • Excellent communication and interpersonal skills for effective team interaction • Excellent organizational skills, attention to detail, and customer service demeanor • Proven strategic planning, risk management, and change management experience • Fluency in English
🏖️ Benefits
• Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities • Privacy-policy and applicant-data protection provisions
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