Overview

Broad role across all scientific functions in very collaborative environment

Successfully manage and oversee sponsor and investigator oncology clinical trials.

Work directly for a biopharmaceutical company.

Flexible work from home arrangements

Competitive remuneration package

About the Company

Race Oncology (ASX: RAC) is an Australian (ASX-listed) clinical stage, biopharmaceutical company with a dedicated mission to develop new treatments that make a substantial difference to oncology patients. We work with a variety of leading Australian and international research partners and contract research organisations to rapidly progress our therapeutic programs. We are seeking an experienced Senior / Clinical Project Manager who will be responsible for clinical trial execution and life cycle management across Clinical Operations, Medical, Regulatory and Quality.

This is a high-impact opportunity for a professional seeking to apply their expertise in a smaller, collaborative and supportive work environment, while still aligning with the standards and systems of a globally recognised pharmaceutical organisation.

About the Role

Reporting to the Vice President of Clinical, you will be responsible for operational oversight of clinical trials from planning thorough to close-out, acting as a subject matter expert on the assigned protocols and supporting regulatory documentation and submissions. You will lead the integration of essential trial-related documentation and quality systems. You will liaise and work with clinical experts in oncology and related disciplines. This is a cross-functional role requiring close collaboration with other members of the Race Preclinical and Clinical teams, external CROs, and the trial site staff.

Key Duties and Responsibilities

Provide input and oversee management of assigned clinical trials in accordance with ICH-GCP, local regulations, specifically Australian regulatory environment, and company SOPs

Act as a protocol subject matter expert (SME) and contribute to responses to regulatory authority questions on protocol and trial conduct

Develop, review and maintain key study documents, including but not limited to protocols, IBs, ICFs, CRFs and all study manual/plans ensuring alignment with ICH-GCP

Input into, where appropriate, sections of regulatory submission/s related to clinical operations and study design

Contribute to the development, drafting, optimisation and review of work instructions, SOPs and quality related documentation

Management of internal quality system for clinical/GxP document management

Work cross functionally to progress trials and report updates to senior teams including key risks and other matters

Undertake tasks delegated by senior team members to assist other company projects

Liaise with other scientific and commercial team members to ensure all relevant Race Oncology employees are fully aware and have opportunity to give input into decisions.

Essential for the role

Bachelor's degree or higher in life science; advanced degree in relevant area preferred

Minimum 5 years of experience working in Clinical Operations within the biopharmaceutical industries and/or Clinical Research Organisation (CRO) including a role with primary responsibility for clinical study execution and management

Operational and direct managerial experience in the planning, executing and reporting of clinical studies with experience interacting with senior stakeholders and regulatory bodies

Demonstrated experience acting as a protocol SME

Strong working knowledge of clinical quality systems and ICH-GCP as well as relevant local regulations

Proven ability to draft, revise and implement SOPs

Proven flexibility, collaborative skills and adaptability in a remote working setting

Eagerness to drive timely milestones and outcomes

Willingness to “roll up your sleeves” and do what is required to progress projects

Excellent attention to detail, with strong written and verbal communication skills

Excellent time management and prioritisation skills

Ability to work autonomously

Full Australian work rights

Desirable for the role

Oncology experience

Knowledge of pharmacokinetics

Prior exposure to multi-national regulatory submission

Experience in small to mid-size sponsor environments

Integrity and high ethical standards