About the Company

Diagnexia, a subsidiary of Deciphex: Accelerating Certainty and Pioneering Pathology Services.

Diagnexia, a leading provider of pathology services, operates as a subsidiary of the parent company, Deciphex. Established in Dublin in 2017, Deciphex has rapidly expanded to become a global team of over 150 professionals, offering innovative software solutions to address the pathology gap in both research and clinical areas. With a mission to accelerate the drug development process and provide timely, accurate diagnoses for cancer patients, Deciphex has established a strong presence through its offices in Dublin, Exeter, Oxford and Chicago.

As part of the Deciphex family, Diagnexia leverages its expertise to provide cutting-edge diagnostic solutions to healthcare organizations worldwide. Our cloud-based platform enables hospitals to easily and rapidly send cases for a consultation to our team of expert subspecialists. We are dedicated to improving patient outcomes and helping healthcare organisations stay at the forefront of the industry.

We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients. Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.

We are looking for highly motivated individuals who are excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.

About this Role

We're seeking an experienced Manager of Pathology Studies in Clinical Trials to join our growing team. The Manager will lead pathology-related projects in clinical trials, ensuring they align with specified timelines, quality standards, and client expectations. Integral to this role is developing and maintaining comprehensive project dashboards and metrics, enabling effective tracking and reporting of project progress. The Manager will act as the primary liaison between our team and our clinical trial customers, ensuring that all aspects of the trials are executed flawlessly. This role requires a deep understanding of how pathology activities integrate into clinical trial processes, the ability to write comprehensive clinical reports and verify the accuracy and completeness of scoring templates. The Manager will facilitate our clinical trial services, ensuring high-quality outcomes and customer satisfaction.

This role demands strong relationship-building skills and clear, consistent communication. Collaboration with cross-functional teams is essential, requiring the manager to facilitate seamless integration of project requirements while fostering a cooperative and productive working environment. The manager's strategic planning and keen analysis of project metrics will guide continuous process optimization and inform business growth strategies.

About this Role (Responsibilities):

• Oversee and manage all project-based work from clients or customers, including clinical trials contracts, lab manuals and slide digitization.
• Act as the main point of contact for clients, representing the company in project-related communications and meetings; organize meeting schedules for projects internally and externally.
• Conduct thorough requirement gathering for each project to fully understand client needs and expectations; document and report findings to stakeholders.
• Collaborate with key internal stakeholders to define, document, and assess the scope and parameters of projects, including deliverables, timelines, and resource estimates; communicate these clearly to all stakeholders.
• Collaborate with the pathologist management team and lab teams to ensure alignment of project objectives and requirements within considered timelines.
• Ensure targeted and transparent communication with key stakeholders on troubleshooting, documenting tracking of implemented decisions/procedures, and providing appropriate training as required.
• Develop and execute project plans, including workflow diagrams and comprehensive documentation of all project elements to ensure effective project execution.
• Monitor and track project progress, identify deviations or issues, and take corrective action as needed; implement dashboards to track performance metrics and statistics for all projects.
• Track improvements in project performance over time and provide detailed and regular updates to key stakeholders on project status and developments.
• Collaborate with various departments and stakeholders within the organization for integrated project execution, including the quality team, operations team, integration team, and IT teams.
• Manage project risks and implement contingency plans to maintain project flow.
• Ensure project execution adheres to relevant industry standards, regulations, and company policies.
• Develop external-facing materials to showcase the services we offer.
• Lead cross-functional team efforts to ensure project success, facilitating effective collaboration between pathologist management, lab, quality, and operations teams.
• Demonstrate strategic foresight in project planning to anticipate challenges and align project goals with broader company objectives.
• Coordinate the pathology aspects of clinical trials, including the logistics of slide preparation, digitization, image analysis study design and execution, pathology scoring, reporting, and delivery.
• Ensure compliance with clinical trial protocols, maintaining accurate and complete documentation for pathology-related activities.
• Generate, review and disseminate clinical study protocols to relevant stakeholders.
• Assist in preparing clinical study reports, final reports and any other trial-related documents, including if needed, for regulatory authorities and ethics committees.
• Manage the scheduling and coordination of pathology reviews, image analysis activities, and meetings, ensuring all stakeholders are informed and prepared.
• Ensure accurate and timely data entry for pathology-related metrics in clinical trial databases.
• Liaise with customers clinical trial coordinators and other clinical staff to ensure smooth integration of pathology services into the overall trial workflow.
• Review pathology reports and scoring templates to ensure they meet clinical trial requirements and standards prior to submission to the CMO/CSO or deputy for approval.
• Ensure adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements in all clinical trial activities.
• Stay updated with the latest developments in GCP and other relevant regulatory guidelines to ensure compliance.
• Provide training and support to staff involved in clinical trial pathology processes to ensure adherence to protocols and quality standards.

Required Skills and Experience:

• PhD in a life sciences.
• Knowledge in the digital pathology field, with 1-2 years’ experience
• Strong experience in clinical trials management.
• Proven experience in a project management role.
• Ability to work tactically and respond dynamically to any troubleshooting requirements.
• Experienced user of data analysis tools beyond Excel and other MS Office tools
• Proficient numerical ability to record, interpret and analyze complex data
• Excellent understanding of clerical principles, such as proper organization of important documents
• Superb decision-making and critical thinking skills
• Experience with GCP regulations or software will be ‘a distinct advantage’.

• Familiarity with regulatory requirements and submission processes for clinical trials (e.g., FDA, EMA.
• Experience with quality management systems (QMS) and standard operating procedures (SOPs).
• Prior experience in managing pathology endpoints in clinical trials.
• Excellent report writing skills.
• Strong project management skills with the ability to handle multiple projects simultaneously.
• Excellent communication and interpersonal skills for effective client interaction and team coordination.
• Knowledge of GCP standards and experience in implementing tracking and enforcing GCP protocols via clear communication channels.
• Ability to draft detailed Gantt/project documents and training materials.
• Familiarity with clinical trials, slide digitization processes, and image analysis technologies.
• Experience in conducting and supporting audits.

What are the benefits of working with Deciphex?

• A true sense of meaning in your work by contributing to better patient outcomes.
• The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment with.
• A chance to work on exciting and challenging unique projects.
• Regular performance feedback and significant career growth opportunities.
• Competitive salary with performance based annual increments.
• A highly collaborative and supportive multi cultural team.

Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the traveling community or any other classification protected by applicable law.