Director, Study Start Up – EU

Job not on LinkedIn

🔥 5 minutes ago

🌐 Poland, Spain – Remote

🇵🇱 Poland – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 10%

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Premier Research

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

💰 Venture Round on 2016-10

Healthcare • Consulting • Biotechnology

Premier Research is a company dedicated to helping biotech companies transform groundbreaking scientific ideas into life-changing medical treatments. They specialize in clinical research and development, product development and regulatory consulting, and offer expertise in areas such as oncology, hematology, rare diseases, cell and gene therapy, and pediatrics, among others. Premier Research is committed to boosting clinical development strategies and guiding innovations from molecule to market. They provide a range of services that support biotech firms in navigating the complex path to medical approval, with a focus on rare diseases and innovative therapies.

📋 Description

• Lead the Study Start Up group, including SSUAs and SSUA Managers, within assigned regions • Develop and execute business strategy aligned to project delivery • Performance-manage and develop staff while striving for operational excellence • Interact directly with clients to support repeat business • Collaborate with Project Management, Clinical Leadership, and Business Development to manage contracts and client expectations • Lead SSU activities including essential document collection, EC/IRB submissions, site initiation, Ethical Committee submissions, and close collaboration with site teams • Drive process improvements and develop training materials • Manage teams to deliver departmental metrics supporting business initiatives • Resolve and escalate complex risks and issues using root-cause analysis • Oversee SSU performance and teams within assigned regions • Manage staffing, resources, and departmental utilization • Drive teams to meet project timelines • Partner with the VP to improve and streamline global SSU processes • Collaborate with SSU management in the US and other regions • Ensure SSU processes are proactive and completed according to contractual agreements • Apply risk-management principles and identify productivity and cost-reduction opportunities • Contribute to business development and proposal specifications • Participate in metric reporting and management meetings • Identify resourcing and staffing for new studies • Manage and mentor direct reports, including training, performance management, and career development • Prioritize multiple assignments in a fast-paced environment • Ensure transition planning and stakeholder communication for staff changes • Review and advise on SSU-related SOPs, WGs, and ADs • Share knowledge with other managers • Produce concise internal and external documentation and presentations

🎯 Requirements

• Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, scientific or health related field • 7-9 years of related experience in health sciences • Clinical trials support or pharmaceutical industry experience preferred • Direct experience in study start up roles highly preferred • 5-7 years of personnel management and oversight of larger groups preferred • Expertise in ICH/GCP and/or ISO14155 requirements • Detailed knowledge of relevant country-specific regulatory drug/device research and development requirements for conducting clinical trials • Working knowledge of FDA, European Regulatory and EC procedures as applicable • Knowledge of site and institution-specific contract requirements

🏖️ Benefits

• Flexibility and balance to support your life • Growth, skills, and career development opportunities