Overview

Are you ready to take the reins of global clinical trials from anywhere in the world? Ergomed is hiring a Specialist or Senior Specialist in Study Start Up and Regulatory Affairs for a fully remote position that you can do from any location globally. If you love navigating complex regulatory pathways and getting clinical sites ready for action, this opportunity lets you make a real impact while enjoying complete location independence.

Key Responsibilities

Lead and coordinate all activities required to achieve site initiation readiness on time.
Deliver assigned study start up and regulatory milestones within your defined scope.
Make independent decisions regarding regulatory processes and documentation approaches.
Manage medium complexity regulatory environments, including multi-country requirements.
Lead study start up and regulatory activities for assigned regions, ensuring strict adherence to quality and timelines.
Prepare, review, and perform quality control on regulatory and start up documentation like submissions, essential documents, and translations.
Draft, negotiate, finalize, and execute clinical site agreements and ancillary contracts.
Act as the primary liaison between internal teams, clients, and external stakeholders.

Requirements

Solid experience in clinical research, specifically focusing on study start up and regulatory affairs.
Strong working knowledge of ICH-GCP guidelines and country-specific regulatory requirements.
Proven ability to handle multi-country requirements and medium-complexity regulatory environments.
Excellent communication and negotiation skills for managing clinical site and ancillary agreements.
Strong attention to detail and a track record of meeting strict project timelines.

What You'll Gain

The freedom to work 100 percent remotely from anywhere in the world.
A chance to work with a talented global team dedicated to innovative clinical research.
Continuous professional development and opportunities to handle diverse, international projects.
Competitive compensation and a supportive remote work culture.