Director, Site Start-up

🔥 0 minutes ago

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

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

⏰ 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 support to the Site Start-up team across project delivery, communication, human resources, revenue enhancement, procedures, systems and processes • Support management and oversight of site start-up delivery, including IRB/EC submissions, Competent Authority submissions, governing organizations, site contracts and budget negotiations • Establish the PFM Site Start-up framework with the Head of Site Start Up, including intelligence, tools, methodology, risk evaluations and mitigations • 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 or complex SSU programs • Manage escalations and remediation of SSU concerns • Optimize processes and delivery to meet or exceed budget targets • Partner with Global Resourcing on assessment and management of SSU team members • Support career development, growth and succession planning while ensuring compliance with company policies and regulatory guidelines • Coordinate SSU Lead participation in client meetings and presentations • Collaborate with Business Development on opportunity development, proposals, budgeting and bid defenses • Support SSU project strategy, delivery, evaluations and required changes • Develop, measure and report SSU KPIs and lead continuous improvement • Reinforce PFM 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