Director, Site Start Up

🔥 7 minutes ago

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

🇪🇸 Spain – Remote 🇬🇧 United Kingdom – 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 overall site start-up delivery through direct management and cross-functional oversight of IRB/EC submissions, Competent Authority submissions, site contracts, budget negotiations, and other start-up requirements • Establish the Precision for Medicine Site Start-up framework, including intelligence, tools, methodology, risk evaluations, and mitigations • Support collaboration with Clinical Operations, project management, and other functions in planning, execution, and governance of global and regional Site Start-up activities • Support corporate and departmental business strategies with the Head of Site Start Up • Act as an ambassador for change management supporting global structural evolution, growth, and expansion • Provide leadership and oversight for large or increasingly complex Site Start-up programs • Manage escalations and remediation of Site Start-up concerns • Optimize processes and delivery to support profitability and budget performance • Partner with Global Resourcing to assess and manage team members and ensure cost, time, and quality goals • Support team career development, growth, and succession planning while ensuring compliance with company policies and regulatory guidelines • Coordinate Site Start-up Lead participation in client meetings and presentations • Collaborate with Business Development on opportunity development, proposals, budgeting, and bid defense • Work with global and regional functional leaders to support project strategy and delivery • Support Site Start-up evaluations and implement required project changes • Develop, measure, and report Site Start-up KPIs and lead continuous improvement • Reinforce Precision for Medicine culture and values, motivate the team, maintain engagement, and drive retention

🎯 Requirements

• Bachelor's degree in life sciences or a 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