Senior Clinical Project Manager
Senior Clinical Project Manager
Posted on :
11-05-2025
Employer Active
1 Vacancy
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Job Description
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 Telixs clinical trials. The SCPM is responsible for the successful execution of national and global clinical trials (early phase to registration) from protocol conception startup 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 studyrelated 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 multinational multicenter 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 crossfunctional 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
- A minimum of a Bachelors degree in life sciences PMP preferred
- At least 5 years of relevant experience in Clinical Trial Project Management.
- Experience with late phase clinical trials (Phase 3 4 registration trials) oncology and/or radiopharmaceutical experience preferred.
- Excellent oral and written communication organizational and problemsolving 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 recordkeeping environment.
- Demonstrated leadership skills and ability to cultivate development of others
- Startup experience (country and site feasibility ethics & regulatory submissions in multiple regions (APAC EMEA NA)
- Flexibility in work hours that cater to international time zones across the US AsiaPacific and EMEA
- Ability to travel
- Strong focus on quality work
- Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments
Key Capabilities:
- Strong communication skills effective across all levels of the organization.
- Extensive experience in Regulatory Affairs particularly with the TGA in Australia and ideally experience working with regulatory authorities across the AsiaPacific region.
- Proficient understanding of both early and latestage drug development processes including clinical and nonclinical requirements at an advanced level.
- Strong ability to collaborate effectively with teams across the region.
- Demonstrate a dedication to continuous learning and professional growth actively pursuing opportunities to enhance your expertise and skill set.
- Uphold integrity and exhibit a steadfast commitment to ethical conduct in all dealings with colleagues and stakeholders.
Required Experience:
Senior IC
Employment Type
Contract
Key Skills
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