Clinical Trial Manager

Study Delivery 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.

Clinical Trial Manager (CTM)

Job Purpose:

• Clinical Trial Manager (CTM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost, and quality, and ensuring inspection readiness by taking oversight of study eTMF completeness.

• The CTM role is designed to have a broader impact on the business by driving continuous improvement initiatives within their remit of expertise, sharing best practices across the business, with a focus on increasing operational delivery efficiency.

Key Responsibilities:

• CTM works in close partnership with the Study Delivery Lead (SDL) on end-to-end operational study delivery activities, from study setup to study archival, with a focus on setting up, maintaining, and ensuring completeness of internal systems, databases, tracking tools, and project plans (CSAP).

• CTM works cross-functionally with internal and external partners on clinical study management activities, as agreed with the Study Delivery Lead, for in-house and outsourced studies across all phases and therapeutic areas, in accordance with the Study Team Operating Model (STOM), current clinical study regulations, and ICON procedures, policies, best practices, and standards. The CTM plays a key role in successful study delivery by providing subject matter expertise across key processes and systems throughout the study lifecycle.

• CTM is responsible for monitoring study conduct and progress, identifying, resolving, and escalating risks and issues that may impact delivery of the study to required quality, timeline, and budget objectives.

• CTM is responsible for reviewing key clinical documents, including Protocols and Informed Consent Forms, and for leading the development of study plans (e.g., Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan, etc.) for internal and external use in assigned studies.

• CTM facilitates and maintains interactions and meetings with internal stakeholders (including regulatory, LOC, quality assurance, monitors) and external partners (including CROs and third-party vendors) to ensure successful delivery of assigned studies.

• CTM is responsible for vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables, and ensuring continued monitoring and timely delivery of activities delegated to third parties.

• CTM is responsible for country oversight, acting as a primary point of contact, tracking recruitment progress, data completeness, and compliance, and overseeing protocol deviations, risks, regulatory approvals, and import license status.

• CTM coordinates study-related activities and manages study team communications, including meetings (preparation, scheduling, minutes), information spaces, newsletters, action logs, communication plans, and team lists.

• CTM oversees delivery of clinical supplies, investigational products, and all study materials provided by ICON or external service providers, communicates risks to supply continuity, and proposes mitigation solutions as appropriate.

• CTM ensures data oversight to maintain inspection readiness at all times, including oversight of eTMF completeness (eTMF setup, periodic reviews, follow-up on missing documents, safety report dissemination), ensuring documents are complete and quality-checked.

• CTM supports budget oversight activities, including management of task and change orders, expense tracking, reconciliation across systems and agreements, and escalation of financial issues to the SDL.

• CTM actively contributes to squads (potential Scrum Master role within the Global Study Team), acting as a mediator by breaking down barriers, strengthening team dynamics, building business agility, and embracing change.

• CTM performs the full scope of activities independently and has the seniority to support all study types and operational scenarios requiring clinical trial expertise, with limited instruction from the SDL.

• CTM acts as a mentor and coach for less experienced colleagues.

Education Requirements (minimum expected):

• University degree or equivalent, preferably in medical, biological, or life sciences, or a discipline associated with clinical research.

Job-Related Experience (minimum requirements):

• At least 10 + years of relevant experience in a pharmaceutical, biotech, CRO, or scientific environment.

• Strong knowledge of clinical trials and drug development processes.

• Excellent knowledge of ICH-GCP and clinical study delivery processes, including regulations, operational best practices, and industry standards.

• Experience using key clinical trial systems, including Trial Master File (TMF) systems aligned with industry standards.

• Strong project management skills; analytical and financial skills are an advantage.

• Excellent verbal and written communication skills in English.

• Strong relationship-building and stakeholder management skills, including management of external service providers.

Other Job-Related Skills:

• Strong understanding and application of applicable clinical trial regulatory requirements, including GCP and ICH guidelines.

• Ability to manage multiple competing priorities across studies with effective planning, time management, and prioritization skills.

• Ability to work independently, analyse and solve problems systematically and creatively using a risk-based approach.

• Demonstrated expertise and seniority within the clinical trial operations function.

• Strong analytical thinking, attention to detail, and a quality-focused mindset, with the ability to identify trends, risks, and outliers.

• Solid understanding of project planning and project management principles.

• Working knowledge of project finance and accounting to support budgets, invoices, cross-charges, and expense reviews.

• Strong proficiency in Microsoft Office tools (Excel, PowerPoint, Word, Outlook); advanced Excel, timeline/budget tracking systems, and CTMS experience are an asset.

• Excellent interpersonal, communication, and stakeholder management skills, with the ability to influence at all levels of the organization.

• Results-driven, motivated, and adaptable, with the ability to thrive in a dynamic and changing environment and coach teams to focus on value and agility.

• Ability to work effectively within cross-functional squads using an agile delivery model.

• Strong team spirit and ability to work across cultures and geographies with cultural awareness and sensitivity.

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.

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