Senior Clinical Project Manager

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