Senior Clinical Project Manager

Telix Pharmaceuticals (AMER)

11d

About The Position

The Senior Clinical Project Manager (SCPM) reports to the Senior/Director of Clinical Operations, who has primary responsibility for executing Telix’s clinical trials. The SCPM is responsible for successful execution of national and global clinical trials, from early phase through registration, covering the process from protocol conception and study start-up through the clinical study report. The role manages project documentation, budgets, safety, quality, and teams, and ensures study deliverables are completed while proactively identifying and resolving project issues. Problem solving, critical thinking, teamwork, and flexibility are vital to success. The SCPM manages complex multinational, multicenter research projects and works with external partners, sites, vendors, and cross-functional teams. The position also develops project delivery strategies, supports bid defenses, negotiates contracts and budgets, communicates trial status and risks, and mentors study team members and CPMs. Travel of approximately 10% is expected.

Requirements

Bachelor’s degree in life sciences.
At least 5 years of relevant clinical trial project management experience.
Excellent oral and written communication, organizational, and problem-solving skills, including the ability to work under strict timelines.
Team-oriented mindset and ability to work with cross-functional teams.
Experience managing global clinical trials.
Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes.
Ability to pivot study strategy quickly and lead teams in the appropriate direction.
Strong analytical, organizational, planning, decision-making, negotiation, and conflict-management skills.
Fluency in Microsoft Office, including Word, Excel, SharePoint, and Teams, and experience working in a primarily electronic record-keeping environment.
Demonstrated leadership skills and ability to support the development of others.
Start-up experience, including country and site feasibility and ethics and regulatory submissions in multiple regions (APAC, EMEA, and North America).
Expected travel of approximately 10%.
Inclusive mindset and appreciation for diversity.
Creativity and willingness to develop innovative solutions.
Commitment to excellence and achieving measurable results.
Ethical behavior and integrity in interactions with colleagues and stakeholders.
Adaptability to changing priorities and new challenges.
Strong communication and collaboration skills.
Resilience in responding to setbacks and challenges.
Commitment to continuous learning and professional development.

Nice To Haves

PMP certification preferred.
Experience with late-phase clinical trials (Phase 3–4 or registration trials), oncology, and/or radiopharmaceuticals preferred.

Responsibilities

Manage trial activities, including vendor selection, site feasibility and selection, timelines, budgets, resources, and vendor relationships, from protocol finalization through study closeout.
Forecast spending and identify opportunities to accelerate activities or changes in spending timelines.
Develop integrated study management plans with the core project team.
Develop and manage study documents, including protocols, informed consent documents, and clinical manuals, and implement quality standards.
Monitor external partners’ work to ensure service quality and adherence to agreed timelines and budgets.
Ensure effective project plans are in place and operational for each trial in accordance with applicable SOPs.
Proactively manage risks and lead problem-solving and resolution efforts.
Support development and maintenance of clinical SOPs and trial processes.
Develop project delivery strategies for RFPs and lead bid defense preparations; understand project strategy and translate the agreed approach into delivery.
Manage complex multinational, multicenter clinical research projects.
Develop patient recruitment strategies.
Negotiate contracts and budgets with sites and vendors.
Communicate trial status, issues, and mitigations to leadership and relevant cross-functional stakeholders.
Train study team members and mentor CPMs.
Work independently with limited supervision.
Attend medical conferences and represent clinical operations through investigator engagement and/or presentations.