Senior Site Contracts Lead

🔥 0 minutes ago

🌐 Bulgaria, Italy, +2 more countries – Remote

🇧🇬 Bulgaria – Remote 🇮🇹 Italy – Remote 🇪🇸 Spain – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

👻 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

• Manage all aspects of implementing Non-Disclosure Agreements, Clinical Trial Agreements, Contract Amendments, and associated documents for assigned studies • Oversee Site Contracts with country experts during investigator site negotiations • Lead negotiation of Site Contract templates with Sponsors and liaise between Sponsors and country experts • Assist with developing and maintaining CTA, NDA, and other document templates to ensure compliance with local legal requirements • Support the quality of all Site Contracts • Identify site contract and budget-related risks and suggest mitigation solutions • Represent the Premier Research Contracts Department during Sponsor Kick-Off meetings • Oversee site contract-related study timelines, milestones, deliverables, and deadlines • Review and advise on Regulatory and Clinical Operations SOPs, working groups, and advertisements related to NDAs, CTAs, investigator grants, and letters of authorization of Powers of Attorney

🎯 Requirements

• Undergraduate degree or its international equivalent in legal studies or life sciences from an accredited institution • 5+ years of Contract Lead experience in clinical research or a related industry • Experience overseeing Site Contracts negotiation teams at regional/global level • Knowledge of basic requirements of contracts, non-disclosure agreements, powers of attorney, and related documents • Knowledge of privacy laws and regulations pertaining to cross-border data transfer • Knowledge of ICH/GCP regulations • Working knowledge of FDA Guidance Documents, EU Regulations, local regulations, and ISO 14155 regulations • Knowledge of drug/device development and clinical monitoring procedures

🏖️ Benefits

• Flexibility and balance to support your life • Skills and opportunities for professional growth