Clinical Project Manager (CPM)

Planet Pharma

Sydney

Remote

AUD 120,000 - 150,000

Full time

41 hours ago
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Job summary

Planet Pharma is seeking an experienced Clinical Project Manager to lead studies from start-up to close-out. You will manage timelines, budgets, and cross-functional teams while serving as the primary liaison between sponsors and sites.

The role requires a Bachelor's degree, at least 5 years of clinical trial experience, 2+ years as a PM in clinical research, proficiency in ICH-GCP, and travel up to 25%. You will ensure regulatory compliance and high-quality study delivery.

Qualifications

  • Bachelor’s degree in science/healthcare (preferred).
  • Minimum 5 years’ clinical trial experience in pharma/biotech/CRO/healthcare.
  • At least 2 years’ project management experience in clinical research.
  • Experience overseeing CRA activities and study execution.
  • Strong understanding of clinical development and drug development processes.
  • Sound knowledge of ICH-GCP and regulatory requirements.
  • Excellent communication, stakeholder management, and organizational skills.
  • Ability to work effectively in a cross-functional environment.
  • Proficiency with Microsoft Office applications.
  • Willingness to travel up to 25%.

Responsibilities

  • Lead the planning, execution, monitoring, and close-out of clinical studies.
  • Manage study timelines, scope, budgets, and overall project deliverables.
  • Coordinate and oversee cross-functional project teams.
  • Act as the primary liaison between sponsors, sites, and internal stakeholders.
  • Lead internal and external project meetings.
  • Track study progress and provide regular status updates to stakeholders.
  • Identify, mitigate, and escalation project risks as required.
  • Maintain clinical trial management systems and study documentation.
  • Review and contribute to key study documents, including protocols, informed consent forms, and study plans.
  • Monitor study budgets and support change control processes where required.
  • Ensure compliance with applicable SOPs, ICH-GCP guidelines, and regulatory requirements.

Skills

Clinical project management
Stakeholder management
Cross-functional collaboration
Documentation & QA
MS Office

Education

Bachelor’s degree in science/healthcare

Tools

Microsoft Office

Job description

Location: Remote Australia
Employment Type: Permanent
Reporting To: Clinical Operations head.

Clinical Project Manager
Overview

Our client is seeking an experienced Clinical Project Manager to lead the delivery of clinical studies from start-up through to close-out. This role will oversee study planning, execution, timelines, budgets, and cross-functional coordination while serving as the primary point of contact between sponsors, internal teams, and investigative sites.

The successful candidate will work closely with stakeholders across clinical operations, biostatistics, data management, medical writing, safety, medical monitoring, and clinical monitoring to ensure the successful delivery of clinical programs in compliance with regulatory requirements and company procedures.

Key Responsibilities
  • Lead the planning, execution, monitoring, and close-out of clinical studies.
  • Manage study timelines, scope, budgets, and overall project deliverables.
  • Coordinate and oversee cross-functional project teams.
  • Act as the primary liaison between sponsors, sites, and internal stakeholders.
  • Lead internal and external project meetings.
  • Track study progress and provide regular status updates to stakeholders.
  • Identify, mitigate, and escalation project risks as required.
  • Maintain clinical trial management systems and study documentation.
  • Review and contribute to key study documents, including protocols, informed consent forms, and study plans.
  • Monitor study budgets and support change control processes where required.
  • Ensure compliance with applicable SOPs, ICH-GCP guidelines, and regulatory requirements.
Requirements
  • Bachelor’s degree, preferably in a scientific or healthcare-related discipline.
  • Minimum 5 years’ clinical trial experience within a pharmaceutical, biotechnology, CRO, or healthcare environment.
  • At least 2 years’ project management experience within clinical research.
  • Experience overseeing and supporting CRA activities and study execution.
  • Strong understanding of clinical development and the drug development process.
  • Sound knowledge of ICH-GCP and relevant regulatory requirements.
  • Excellent communication, stakeholder management, and organisational skills.
  • Ability to work effectively in a cross-functional environment.
  • Strong proficiency with Microsoft Office applications.
  • Willingness to travel up to 25% as required.
Ideal Profile
  • Proven clinical project management experience with responsibility for timelines, budgets, and study delivery.
  • Strong leadership and stakeholder management capabilities.
  • Comfortable operating in a fast-paced, collaborative clinical research environment.
  • Proactive, detail-oriented, and able to manage multiple priorities simultaneously.
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