Portfolio Director, Clinical Trials & Strategy

CMAX Clinical Research; Adelaide; On-site; AUD 180,000 - 260,000; Full time

Job summary

CMAX Clinical Research, located in Adelaide, Australia, seeks two Project Directors to provide strategic oversight across a portfolio of clinical trials from feasibility to close-out. You will partner with sponsors and senior leaders to ensure studies are deliverable, well-governed and on track.

You will lead governance, risk management and escalation for complex studies, liaising with Practice Leads, Clinical Project Managers and operational teams.

Qualifications

• Tertiary qualification in science/health, project management or related field, or substantial equivalent experience.
• Current ICH GCP Certificate is required.
• Extensive clinical research project or portfolio-management experience.
• Experience overseeing multiple complex studies from opportunity/start-up to close-out.
• Strong knowledge of clinical trial standards, SOPs, quality systems and ICH GCP.
• Ability to define study scope, timelines, assumptions, dependencies and risks.
• Experience managing operational risk, quality incidents, CAPAs and escalations.
• Demonstrated experience building sponsor relationships.
• Experience overseeing external service providers or vendors.
• Strong commercial and operational judgement; excellent communication and stakeholder-management skills.
• Ability to coach and mentor others without formal line-management authority.

Responsibilities

• Oversee end-to-end lifecycle and performance of a portfolio of studies.
• Provide strategic direction, governance and escalation support to meet timelines and quality standards.
• Collaborate with Practice Leads, Clinical Project Managers and other functions.
• Coach study team members and share lessons learned across the Study Team.
• Contribute to major operational projects and continuous improvement initiatives.

Skills

Clinical leadership

Stakeholder management

ICH GCP knowledge

Strategic planning

Portfolio governance

Risk management

Sponsor relationships

Vendor oversight

Negotiation & influence

Coaching without authority

Education

Tertiary qualification in science/health

Job description

CMAX Clinical Research, located in Adelaide, Australia, seeks two Project Directors to provide strategic oversight across a portfolio of clinical trials from feasibility to close-out. You will partner with sponsors and senior leaders to ensure studies are deliverable, well-governed and on track.

You will lead governance, risk management and escalation for complex studies, liaising with Practice Leads, Clinical Project Managers and operational teams.