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 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 SSU team guidance, leadership and overall support for project delivery, communication, human resources, revenue enhancement, procedures, systems and processes • Support overall management of site start-up delivery through direct management and/or cross-functional oversight of IRB/EC submissions, Competent Authorities submissions, governing organizations, site contracts and budget negotiations • Establish the PFM SSU framework with the Head of Site Start Up, including SSU intelligence, tools, methodology, risk evaluations and mitigations • Support collaboration with Clinical Operations, project management and other cross-functional departments in planning, execution and governance of SSU activities • Support corporate and departmental business strategies • Act as an ambassador for change management supporting global structure evolution, growth and expansion • Provide leadership and oversight on large or increasingly complex SSU programs • Manage escalations and remediate SSU concerns • Optimize processes and delivery to support SSU profitability and budget targets • Partner with Global Resourcing to assess and manage SSU leads, specialists and site contract management staff • Support SSU team career development, growth and succession planning while ensuring policy and regulatory compliance • Coordinate SSU Lead participation in client meetings and presentations • Collaborate with Business Development on opportunities, proposals, budgeting and bid defense preparation • Work with global/regional functional leaders to support SSU project strategy and delivery • Support SSU evaluations and implement required project changes • Develop, measure and report SSU KPIs and lead continuous improvement • Reinforce PFM culture and values to motivate, maintain engagement and drive retention for the SSU team

🎯 Requirements

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