Director, Site Start Up

🔥 3 minutes ago

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

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

💵 zł402.7k - zł604.1k / year

⏰ Full Time

🔴 Lead

👔 Director

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 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 SSU framework with the Head of Site Start Up, including intelligence, tools, methodology, risk evaluation, and mitigation • Coordinate SSU activities with Clinical Operations, project management, and other cross-functional departments globally and regionally • Support corporate and departmental business strategies and act as an ambassador for change management • Provide leadership and oversight for large and increasingly complex SSU programs • Manage escalations and remediate SSU concerns • Optimize processes and delivery to support profitability and budget targets • Partner with Global Resourcing teams to assess and manage SSU team members and meet cost, time, and quality goals • Support career development, growth, succession planning, policy, and regulatory compliance • Support SSU Lead participation in client meetings and presentations • Collaborate with Business Development on opportunities, proposals, budgeting, and bid defense • Support project strategy, delivery, evaluations, and required changes • Develop, measure, and report SSU 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 orientation • Proven experience in strategic planning, risk management, and change management • Fluency in English

🏖️ Benefits

• Discretionary annual bonus • Private medical insurance • MultiSport Card • Life insurance • Pension • Home working allowance • Vacation • Other benefits