Early Access Operations Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Acquire and monitor regulatory approval pathways for all cases; ensure that approvals are gathered, current, and compliant.

• Keep audit-ready documentation in line with industry standards.

• Organize study documents in specified systems (e.g., electronic Trial Master File), maintain essential document lists, and engage in TMF completeness evaluations.

• Initiate and sustain MA/IST contracts and amendments.

• Manage drug supply requests and collaborate with distribution vendors and the vendor manager to track shipments, resolve issues, and guarantee a continuous supply.

• Proactively identify risks and work alongside peers and senior team members to address them.

• Follow departmental processes and uphold high standards of organization and documentation.

• Oversee case monitoring activities to ensure compliance with Good Clinical Practices (GCP) and relevant regional or country-specific regulations.

⛳️ Requirements

• A minimum of two years of experience in healthcare or similar administrative/operational roles with proven adaptability.

• Excellent organizational skills with the capacity to handle a significant volume of small to medium-scope tasks and overlapping deadlines.

• Proactive attitude with the ability to foresee needs and advance cases effectively.

• Capability to adhere to processes and procedures with minimal supervision.

• Strong interpersonal skills and the ability to foster positive working relationships with peers, managers, physicians, and site staff.

• Monitor the emergency request inbox during assigned monthly rotations and appropriately triage urgent treatment requests, including weekends.

• Self-motivated and capable of navigating problems of moderate scope and complexity.

• Familiarity with ICH/GCP.

• Occasional travel may be required.

🏝️ Benefits

• Generous vacation time and public holidays recognized by the company.

• Volunteer days.

• Long-term incentive and Employee stock purchase plans or equivalent offerings.

• Employee wellbeing benefits.

• Fitness reimbursement.

• Tuition sponsorship.

• Professional development plans.