Senior Site Contracts Lead

This is a fully remote position, open to applicants in Bulgaria, +3 more countries.

📋 Description

• Manage the complete process of implementing Non-Disclosure Agreements, Clinical Trial Agreements, Contract Amendments, and related documents for assigned studies.

• Supervise Site Contracts in collaboration with country experts during negotiations with investigator sites.

• Lead the negotiation process for Site Contract templates with Sponsors and serve as a liaison between Sponsors and country specialists.

• Assist in the development and upkeep of CTA, NDA, and other document templates to ensure they comply with local legal standards.

• Ensure the quality of all Site Contracts is maintained.

• Identify risks related to site contracts and budgets, recommending solutions for mitigation.

• Represent the Premier Research Contracts Department at Sponsor Kick-Off meetings.

• Oversee timelines, milestones, deliverables, and deadlines related to site contracts for studies.

• Review and provide recommendations on Regulatory and Clinical Operations SOPs, working groups, and advertisements concerning NDAs, CTAs, investigator grants, and letters of authorization for Powers of Attorney.

⛳️ Requirements

• A bachelor's degree or its international equivalent in legal studies or life sciences from an accredited institution.

• Over 5 years of experience as a Contract Lead in clinical research or a related field.

• Proven experience in overseeing Site Contracts negotiation teams at regional or global levels.

• Familiarity with the fundamental requirements of contracts, non-disclosure agreements, powers of attorney, and similar documents.

• Understanding of privacy laws and regulations concerning cross-border data transfers.

• Knowledge of ICH/GCP regulations.

• Proficient understanding of FDA Guidance Documents, EU Regulations, local regulations, and ISO 14155 regulations.

• Insight into drug/device development and clinical monitoring processes.

🏝️ Benefits

• Flexibility and balance to enhance your personal life.

• Opportunities and resources for professional development.