Project Manager

As a Senior Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Provides Project Oversight & Leadership for Clinical Deliverables:

• Leads and manages the start-up and clinical teams.
• Plans and leads execution of day-to-day activities for the monitoring of a clinical study and communicates consistently with the clinical team providing project objectives, expectations, and status updates.
• Vendor management and budget management, if required
• Works with the team to set priorities.
• Leads and supports the relevant staff (ie, local start-up staff, local and global regulatory affairs staff, in-house clinical staff, etc) to drive successful activation of trial sites.
• Motivates the clinical team.
• Ensures effective communication and escalation plans are place for the clinical team.
• Facilitates cross-functional team communication for proactive, study-wide problem solving regarding study progress and trial issues during the study.
• Monitors the quality of clinical activities and addresses quality issues with the appropriate team member.
• Reviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up, and resolution of site issues.
• Identifies opportunities to improve training, execution, and quality control across the team.
• Liaises with relevant staff to provide data, as required, for clinical operations performance metrics and project status metrics.
• Works with the relevant staff to identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks.

Quality – Training & Development:

• Creates and maintains project-specific plans, documents, and tools for the clinical team.
• Plans, oversees, and conducts initial and ongoing training for the relevant study staff on clinical project specifics.
• Analyzes data related to sites activation, monitoring, data retrieval, and close out to identify issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks; communicates risks and mitigation strategies.
• Supports the CRAs with site monitoring activities and provides suggestions and solutions to site issues, as applicable.
• Ensures all project reporting systems are up to date for clinical activities at the project level.
• Oversees the relevant start-up, regulatory, and in-house clinical staff to ensure all initial or amended trial information is submitted, approved, and filed in accordance with the trial protocol, local regulations, ICH GCP, and any other processes or procedures governing the clinical trial.
• Oversees the relevant regulatory and in-house clinical staff to ensure that all non-safety periodic updates, progress reports, and renewals, and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH GCP, and any other processes or procedures governing the clinical trial.
• Identifies metrics and trends across team members, countries, regions, and uses the information to promote improvement in quality and consistency of execution.
• Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventive action (CAPA) plans, responds completely and accurately to audit reports, and provides team with project-specific audit process to ensure adequate preparations/reviews of all audit responses.
• Organizes project-specific compliance plans for key processes, tools, and systems.
• Reviews filing of Essential Documents in the electronic Trial Master File (eTMF) to ensure sponsor and investigator obligations are being met and comply with applicable local regulatory requirements and ICH guidelines.

Project Team Relations:

• Interfaces with relevant team members and vendors as required to ensure clinical monitoring outcomes are achieved.
• Serves as primary liaison for clinical monitoring issues, interacting with relevant team members and vendors and escalating as required.
• Participates in team meetings, assisting with presentations as required. 

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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, colour, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.