Sr. Clinical Project Manager

Telix Pharmaceuticals (AMER)

3d•Hybrid

About The Position

This role serves as the primary Sponsor operational lead for assigned clinical studies, driving cross-functional alignment across Clinical, Medical, Regulatory, Data Management, Safety, Clinical Supply, CMC, Quality, and external partners. The Senior Clinical Project Manager is responsible for leading the planning, execution, oversight, and delivery of sponsor-led clinical trials in accordance with the protocol, applicable regulations, ICH-GCP, company SOPs, quality standards, timelines, and budget. The Sr. CPM provides proactive oversight of CROs, vendors, investigative sites, study milestones, risks, budgets, and deliverables from study start-up through closeout including clinical study report completion. The role requires strong clinical trial operations expertise, sponsor-side accountability, critical thinking, vendor governance, issue escalation and resolution, and the ability to lead study teams in a complex, fast-paced, and highly regulated environment. This role reports to the Senior Director, Clinical Operations.

Requirements

A minimum of a bachelor’s 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 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, organizational, 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))

Nice To Haves

PMP preferred.
oncology and/or radiopharmaceutical experience preferred.

Responsibilities

Serve as the sponsor operational lead for assigned clinical trials.
Lead cross-functional study teams and drive alignment across Clinical Operations, Medical, Regulatory, Data Management, Biostatistics, Pharmacovigilance/Safety, Clinical Supply, Quality, Legal, Finance, and external partners.
Provide sponsor oversight of selected CROs, vendors, and external partners, including review of performance, quality, deliverables, study metrics, issue trends, escalation pathways, and corrective/preventive actions.
Develop, maintain, and manage integrated study plans, timelines, risk management plans, communication plans, monitoring oversight plans, recruitment plans, and other study-specific operational plans.
Oversee country and site feasibility, site selection, study start-up, regulatory and ethics submissions, site activation, enrollment readiness, and ongoing site performance in collaboration with internal teams and external partners.
Monitor study progress against key milestones, enrollment targets, budget, forecast, and deliverables; proactively identify risks, develop mitigation strategies, and escalate issues appropriately to leadership and governance forums.
Manage study budgets, forecasts, purchase orders, invoices, accruals, change orders, and vendor/site financial oversight in partnership with Finance, Legal, Procurement, and functional stakeholders.
Develop Sponsor required study documents while providing sponsor input into study documents, including protocols, informed consent forms, study manuals, monitoring plans, vendor plans, training materials, newsletters, and operational guidance documents developed by any vendor.
Ensure quality oversight and inspection readiness by supporting TMF/eTMF completeness, protocol deviation oversight, issue management, audit responses, CAPA follow-up, and compliance with sponsor procedures and regulatory expectations.
Partner with study teams and sites to support patient recruitment and retention strategies, remove operational barriers, and ensure enrollment activities remain ethical, compliant, and aligned with trial objectives.
Prepare and communicate study status updates, dashboards, metrics, risks, decisions, and mitigation plans to internal leadership, governance committees, and cross-functional stakeholders.
Lead study team meetings, vendor governance meetings, risk reviews, lessons learned discussions, and operational decision-making forums to promote accountability and timely execution.
Represent Clinical Operations in internal and external meetings, including investigator meetings, vendor meetings, conferences, audits, inspections, and cross-functional governance discussions, as appropriate.