Job Title: Clinical Operations Lead
Location: Remote/Hybrid | Type: Full-time
Reports To: Global Head of Clinical OA
Company: Paradigm Biopharmaceuticals

About the Role
We are seeking a highly experienced and proactive Clinical Operations Lead to oversee and manage the execution of clinical research activities across Australia, the USA, and other international regions. This key role ensures all clinical operations run to timeline, budget, and regulatory compliance, contributing directly to Paradigm’s success in advancing innovative therapeutics.

Key Responsibilities

Lead the delivery of clinical studies according to protocols and agreed timelines, including oversight of CROs and investigative sites.

Manage critical components of clinical operations, including study planning, clinical supply logistics, data/sample/document management, and quality assurance.

Develop and execute study documents such as monitoring plans, procedural manuals, and operational packages.

Conduct regular reviews of study records and monitoring reports, and ensure the Trial Master File is up-to-date.

Support the vendor selection and evaluation process for study-related services.

Serve as Study Project Manager or CRA as needed, overseeing site initiation, monitoring, and closeout.

Chair project meetings, manage action logs, and escalate risks or issues as required.

Uphold compliance with GCP, ICH guidelines, SOPs, and relevant regulatory frameworks (TGA, FDA, EMA).

Identify opportunities for innovation and operational improvement across clinical execution.

About You

8+ years of experience in clinical research.

Certification in Clinical Research preferred.

Strong knowledge of GCP and regulatory standards (TGA, FDA, EMA).

Proven project and vendor management skills.

Excellent communication and leadership capabilities.

Highly organized and self-directed, able to manage multiple priorities in a fast-paced environment.

Comfortable working virtually with limited travel.

Our Values: Transparency | Accountability | Collaboration | Respect | Adaptability | Innovation