Senior Global Clinical Project Manager - Oncology - Fully Remote

ICON plc is a world-leading healthcare intelligence and clinical research organization. ICON has been named 2023 World's Best Large Employers by Forbes Magazine and we would love for you to consider joining our company!

As a Senior Clinical Project Manager you will be joining the brightest minds in the industry to transform clinical research.

What you will be doing:

• For outsourced studies, be the primary point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study;
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;
• Oversee study level performance against agreed upon plans, milestones and key performance indicators by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations;
• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan;
• You will be responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans;
• Lead and coordinate a cross-functional study team of experts to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards;
• Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.
• Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team;
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency);
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development;
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times;
• Provide input and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR));
• Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders;
• Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines;

What we look for:

• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development;
• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;
• Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas;
• Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing;
• At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including 2 years' project management experience - experience on a global level is desirable
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.