Global Study Associate Director (Sr. Clinical Project Manager)

Global Study Associate Director

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What You Will Be Doing:

• Typical Accountabilities:

• 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;

• 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;

• 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;

• 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 all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;

• 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;

• 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;

• 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;

• 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;

• 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 progress reports to the CPT including any financial risks and mitigation plans;

• Ensure studies are inspection-ready at all 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.

Your Profile:

• 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, preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;

• Oncology/hematology experience required

• Must reside in Canada (EST time)

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, 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 perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply