Clinical Operations Manager

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.

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

As Manager Clinical Operations, you will be dedicated to one of our global Biotechnology clients who pride themselves on their quality and patient centric approach. They continue to challenge the status quo whilst ensuring the highest standards of compliance and acknowledging the importance of both global and local expertise

Provides Project Oversight & Leadership for Clinical Deliverables:

• Leads and manages 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.
• Goes to co-monitoring visits as needed
• Vendor management and budget management, if required
• 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.
• 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.

Project Team Relations:

• Leads larger, more complex projects.
• Acts as coordinating manager to ensure consistency of training, processes, and systems-related activities as well as ad-hoc coordinating activities.
• Mentors junior-level staff

You are:

• 5 or more years of experience in clinical research and clinical management, including a minimum of 2 years project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job
• Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution; a licensed healthcare professional, ie, registered nurse
• Demonstrated leadership and people management skills
• Reads, writes, and speaks fluent English; fluent in language of host country
• Oncology experience preferred
• Drug development experience is an asset
• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
• Excellent management skills, developed with a collaborative approach to driving performance and success in a global environment
• Direct experience managing Clinical Research Associates is preferred

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

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 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.