Global Clinical Project Manager - Late Oncology (Canada Remote)

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

• reputed company and coordinate a cross-functional study team of experts to ensure the clinical study reputed company as planned driving achievement of milestones according to timelines, budget and quality standards;
• reputed company and facilitate communication across reputed company functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan;
• For outsourced studies, be the primary reputed company 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 reputed company of the CRO is maintained and documented throughout the lifecycle of the study;
• 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));
• Ensure reputed company external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate reputed company is documented;
• reputed company 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 reputed company are clear to the entire study team;
• reputed company 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;
• Identify and report quality issues that have occurred reputed company the study and collaborate with reputed company functions as necessary to overcome barriers and reputed company milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders;
• reputed company Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in reputed company and that QC activities are performed on an ongoing basis to ensure TMF completeness at reputed company times;
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency);
• 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 reputed company reports to the CPT including any financial risks and mitigation plans;
• Ensure studies are inspection-ready at reputed company times, according to ICH-GCP and SOP and relevant policies/guidelines;
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development;
• 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.

Requirements:

• 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
• 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;
• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development;
• Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing;
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;

Benefits of Working in ICON: Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a reputed company learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of reputed company pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at reputed company stages of your career - both now, and into the future. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. reputed company qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to reputed company the essential functions of a position, please let us know. Apply tot his job Apply To this Job