Clinical Program Manager

Morgan McKinley; Dublin; On-site; EUR 90,000 - 140,000; Full time

Job summary

Morgan McKinley in Ireland is seeking a Clinical Program Manager to lead the delivery of Phase I–IV clinical studies, ensuring alignment with SOPs, regulatory requirements, and GCP. You will oversee study resources, timelines, budgets, and cross-functional collaboration to drive program success.

The role may include people leadership and agency management, with a focus on continuous improvement, risk mitigation, and effective communication with stakeholders across global teams.

Qualifications

• Bachelor's degree in a life sciences discipline or RN with 8+ years of relevant experience.
• Master's degree (MS, PharmD, or PhD) with 6+ years of relevant experience.
• Minimum 4 years cross-functional study management and leadership in life sciences.

Responsibilities

• Lead cross-functional study teams and manage study programs within budgets and timelines.
• Develop and oversee CRO/vendor selection, contracting, and performance.
• Ensure regulatory compliance and QA documentation across studies.
• Coach and develop team members and manage organizational change.

Skills

Cross-functional leadership

Study management

Vendor management

Regulatory knowledge

Clinical operations

Education

Bachelor's degree in life sciences or RN

Master's degree (MS, PharmD, or PhD)

Job description

Clinical Operations is responsible for the global delivery of Phase I–IV clinical trials across a broad range of therapeutic areas. The function plays a critical role in ensuring clinical studies are conducted in accordance with applicable SOPs, company policies, regulatory requirements, and Good Clinical Practice standards, while delivering high-quality clinical data to support successful development, registration, and commercialization.

The Clinical Program Manager will have overall responsibility for the successful delivery of individual studies and/or multiple studies within a program or across multiple programs, including financial oversight. The role will also be responsible for study resource management, including the ongoing evaluation of resource requirements and effective deployment of resources to support a flexible and efficient operating model.

The role will contribute to Clinical Operations and cross-functional organizational change initiatives and may act as a business process owner (BPO) and/or subject matter expert for relevant Clinical Operations processes. The position will promote innovation by identifying and championing new approaches, incorporating external best practices and benchmarking, and supporting standardization and continuous improvement across the organization.

Depending on experience, capabilities, and business requirements, the position may operate as an individual contributor or include people leadership responsibilities. Where applicable, time allocation across study delivery and people management activities will be adjusted accordingly.

People Leader Path:

Responsible for the leadership and development of a team of direct reports.

EXAMPLE RESPONSIBILITIES

• Maintains ongoing financial oversight and accountability for assigned clinical studies and/or programs.
• Contributes, where appropriate, to the development of short- and long-term strategic and operational plans for therapeutic or functional areas and supports effective communication and implementation across relevant teams.
• Provides leadership, direction, and oversight to ensure clinical studies are delivered effectively within agreed budgets, timelines, quality standards, and operational objectives.
• Chairs and/or leads cross-functional Study Management Teams (SMTs), fostering collaboration and influencing key stakeholders to achieve study objectives.
• Works closely with cross-functional partners to develop, monitor, and adjust project timelines, budgets, and delivery plans as required.
• Provides clear and timely communication regarding study progress, risks, challenges, and key decisions, escalating issues appropriately and ensuring project objectives remain on track.
• Contributes to the development, review, and maintenance of study-related documentation, including clinical study protocols and associated operational materials.
• Supports the selection, contracting, oversight, and performance management of CROs and other external vendors, including preparation and evaluation of requests for proposals (RFPs).
• Proactively identifies potential risks, operational barriers, and emerging issues and develops appropriate mitigation and contingency strategies.
• Ensures study activities and decisions remain compliant with applicable national and international regulations, guidelines, and organizational requirements.
• Utilizes appropriate systems, tools, and reporting mechanisms to monitor study and program performance and provide transparent status updates to key stakeholders.
• Contributes to or leads departmental and cross-functional strategic initiatives, process improvements, and organizational projects.
• Supports the development, revision, implementation, and training of SOPs and other relevant operational procedures, as assigned.
• Ensures Clinical Operations activities undertaken locally meet applicable regulatory requirements and established clinical trial practices.
• Ensures team activities are conducted in accordance with approved processes, policies, procedures, quality standards, and regulatory obligations.
• People Leader Path: Recruits, develops, motivates, and retains high-performing and diverse talent; establishes clear objectives and expectations; provides coaching and performance feedback; and supports individual development and career progression.

REQUIREMENTS

The successful candidate will bring a combination of clinical development expertise, strong operational leadership, and the ability to work effectively across complex, matrixed environments.

• Bachelor's degree in a relevant discipline, BS, or RN with 8+ years of relevant clinical or related experience within the life sciences industry; or Master's degree, MS, PharmD, or PhD with 6+ years of relevant clinical or related experience.
• At least 4 years of cross-functional study management and/or related leadership experience within life sciences, including substantial experience leading study or project teams.
• Demonstrated experience in developing RFPs and managing the selection, oversight, and performance of CROs and/or other external vendors.
• Demonstrated success in initiating, managing, and closing clinical studies, including preparation and review of clinical, regulatory, and operational documentation and SOPs.
• Demonstrated proficiency at the Senior Clinical Trial Manager level or equivalent.

Knowledge & Other Requirements

• Advanced knowledge of one or more therapeutic or disease areas, demonstrated through the independent development and execution of study team strategies, deliverables, resource plans, and operational activities.
• Comprehensive understanding of the end-to-end clinical study lifecycle, from study start-up through close-out.
• Strong knowledge of study management methodologies, best practices, and tools, with demonstrated ability to apply these to improve operational efficiency and study performance.
• Thorough understanding of FDA, EMA, and other applicable regulatory requirements, as well as ICH guidelines and Good Clinical Practice (GCP) principles governing clinical research.
• Demonstrated ability to develop and effectively communicate high-quality clinical, regulatory, and operational documentation.
• Strong ability to lead, influence, and drive delivery across programs, projects, and strategic initiatives without relying solely on direct authority.
• Excellent interpersonal skills and a strong understanding of team dynamics and stakeholder management.
• Proven ability to operate effectively within highly matrixed, collaborative, and geographically diverse organizations.
• Demonstrated experience in coaching, mentoring, guiding, and directing others, including supporting performance management and capability development.
• Demonstrated ability to anticipate, navigate, and proactively manage organizational and operational change.
• Excellent written, verbal, organizational, and stakeholder communication skills.
• Willingness and ability to travel as required by the role and study/program needs.