Director, Site Start-Up

🔥 7 minutes ago

🌐 Romania, United Kingdom, +5 more countries – Remote

🇷🇴 Romania – Remote 🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇵🇱 Poland – Remote 🇭🇺 Hungary – Remote 🇷🇸 Serbia – Remote 🇸🇰 Slovakia – Remote

⏰ Full Time

🔴 Lead

👔 Director

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

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 support to the Site Start-Up team across project delivery, communication, human resources, revenue enhancement, procedures, systems, and processes • Manage site start-up delivery through direct management and cross-functional oversight of IRB/EC submissions, Competent Authorities 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 functions on global and regional planning, execution, and governance of Site Start-Up activities • Support corporate and departmental business strategies and change management for organizational growth and expansion • Lead and oversee complex Site Start-Up programs • Manage escalations and remediation of Site Start-Up concerns • Optimize processes and delivery to meet or exceed budget and profitability targets • Partner with Global Resourcing on assessment and management of SSU Leads, SSU Specialists, and Site Contract Management staff • Support team career development, growth, succession planning, and compliance with company policies and regulatory guidelines • Coordinate SSU Lead participation in client meetings, presentations, proposals, budgeting, and bid defenses • Work with global and regional functional leaders to support project strategy and delivery • Evaluate projects and implement required changes • Develop, measure, and report Site Start-Up KPIs and lead continuous improvement • Reinforce company culture and values, motivate the team, maintain engagement, and drive retention

🎯 Requirements

• Bachelor's degree in life sciences or related field, or equivalent combination of education, training, and experience • Minimum 12 years of experience in clinical research, 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 • Excellent organizational skills, attention to detail, and customer service demeanor • Proven experience in strategic planning, risk management, and change management • Fluency in English