Director, Site Start Up

Job not on LinkedIn

🔥 2 hours ago

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

🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇵🇱 Poland – Remote 🇭🇺 Hungary – Remote 🇷🇸 Serbia – Remote 🇸🇰 Slovakia – Remote 🇷🇴 Romania – 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 • Support management and cross-functional oversight of site start-up delivery, including IRB/EC and Competent Authority submissions, 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 collaboration with Clinical Operations, project management, and other functions in planning, execution, and governance of global and regional activities • 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 meet or exceed budget targets • Partner with Global Resourcing to assess and manage SSU leads, specialists, and site contract management staff • Support career development, growth, and succession planning for the SSU team • Coordinate SSU Lead participation in client meetings and presentations • Collaborate with Business Development on opportunities, proposals, budgeting, and bid defenses • Work with global and 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 Precision for Medicine’s culture and values to motivate, engage, and retain the SSU team

🎯 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, such as 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