Biotechnology

Senior Clinical Project Manager

RemoteRemoteFull TimeSeniorPosted 29 days ago

Is this role right for you?

Upload your resume and get a skill-by-skill breakdown — see exactly where you match, where you're close, and what to highlight. Not a mystery percentage.

Get a tailored resume highlighting what this role needs.

Required skills

Clinical Project Management
clinical trials
protocol
start-up
clinical study report
project document development
budget
safety
quality
team management

Nice to have

PMP
oncology
radiopharmaceutical

Role summary

Telix is seeking a Senior Clinical Project Manager (SCPM) to oversee the execution of national and global clinical trials from protocol conception to study closeout. The SCPM will manage all aspects of trial execution, including vendor and site selection, timelines, budgets, resources, documentation, quality, and team management. This role requires a Bachelor's degree in life sciences, 5+ years of experience in Clinical Trial Project Management, and thorough knowledge of ICH GCP and regulatory processes. Experience with late phase, oncology, and/or radiopharmaceutical trials, as well as global trial management, is essential. The SCPM will also mentor junior staff and work independently with limited supervision.

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

The Senior Clinical Project Manager (SCPM) reports to the Senior/Director of Clinical Operations who bears primary responsibility for the execution of Telix’s clinical trials. The SCPM is responsible for the successful execution of national and global clinical trials (early phase to registration) from protocol conception, start-up through the clinical study report, including all aspects of project document development, budget, safety, quality, and team management in an environment where problem solving, critical thinking, teamwork and flexibility are vital to success. The SCPM ensures completion of study deliverables and proactively identifies and resolves clinical project issues.

Key Accountabilities

Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial timelines, budgets, resources, and vendor relationships from protocol finalization through to study closeout.

Forecast and identify opportunities to accelerate activities to bring spend forward or identify if spend will shift.

Independently develop integrated study management plans with the core project team.

Developing and managing all study-related documents such as study protocol, informed consent, clinical manuals, and implementing quality standards.

Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget.

Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs.

Managing risks proactively and leading problem solving and resolution efforts

Support the development and maintenance clinical SOPs & trial process’ as required.

Developing project delivery strategy for RFPs. Lead in bid defense preparations. Understand project strategy and translate the agreed upon approach.

Management of complex multi-national, multi-center clinical research projects

Develop patient recruitment strategies

Conduct contract and budget negotiations with sites and vendors

Communicate trial status, issues, and mitigations to leadership and relevant cross-functional stakeholders

Train study team members and act as mentor for CPMs

Work independently with limited supervision

Attend medical conferences and represent clinical operations through investigator engagement and/or presentations

Education and Experience

Bachelor’s degree in life sciences required, PMP preferred

5+ years of relevant experience in Clinical Trial Project Management required

Experience with late phase clinical trials (Phase 3 - 4, registration trials), oncology and/or radiopharmaceutical experience preferred.

Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines.

Team oriented mindset and demonstrates ability to work with cross functional teams.

Experience managing global clinical trials.

Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes.

Demonstrated ability to pivot study strategy quickly and lead teams in the right direction.

Strong analytical, organisational, planning, decision making, negotiation, and conflict management skills.

Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in working in mainly electronic record-keeping environment.

Demonstrated leadership skills and ability to cultivate development of others

Start-up experience (country and site feasibility, ethics & regulatory submissions in multiple regions (APAC, EMEA, NA))

10% travel to be expected

Key Capabilities:

Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected

Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges

Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do

Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results

Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders

Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges

Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language

Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals

Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges

Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE

Ready to apply?

You'll be redirected to Telix Pharmaceuticals's application page.

Senior Clinical Project Manager

Is this role right for you?

Required skills

Nice to have

Role summary

Similar roles

See how RiseMe works