At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.
The Clinical Trial Manager (CTM) is a valuable member of the global Clinical
Operations Department, which is responsible for the management and execution of
uniQure clinical trials, with a focus on direct work with the study investigators and coordinators, regulations, compliance, timelines, data collection and review, and safety reporting. The CTM is responsible for end-to-end, day-to-day Clinical Operations activities associated with the execution of a clinical trial, including oversight of the Clinical Operations study team, Clinical Research Organizations (CROs), and third-party vendors. The CTM may serve as a Regional CTM that owns activities within a region for a clinical trial or may function as the global CTM that owns the entirety of the project across regions. This position requires both the ability and willingness to perform oversight activities as well as hands-on activities without the support of a CRO. This position is an excellent opportunity for career development as uniQure build out the infrastructure to support its clinical pipeline.
Key result areas (major duties, accountabilities and responsibilities)
The Clinical Trial Manager (CTM) is a valuable member of the global Clinical
Operations Department, which is responsible for the management and execution of
uniQure clinical trials, with a focus on direct work with the study investigators and coordinators, regulations, compliance, timelines, data collection and review, and safety reporting. The CTM is responsible for end-to-end, day-to-day Clinical Operations activities associated with the execution of a clinical trial, including oversight of the Clinical Operations study team, Clinical Research Organizations (CROs), and third-party vendors. The CTM may serve as a Regional CTM that owns activities within a region for a clinical trial or may function as the global CTM that owns the entirety of the project across regions. This position requires both the ability and willingness to perform oversight activities as well as hands-on activities without the support of a CRO. This position is an excellent opportunity for career development as uniQure build out the infrastructure to support its clinical pipeline.
Key result areas (major duties, accountabilities and responsibilities)
- Responsible for leading day-to-day Clinical Operations activities for a clinical trial, including start-up, maintenance and closure, in accordance with, ICH-GCP, uniQure policies and applicable SOPs
- Ensure projects are conducted within timelines, budget, and scope, and with a high degree of quality, and leads Clinical Operations processes for a region or across a selection of vendors to ensure data integrity is maintained, and deviations are acted on by implementing preventative action plans
- Responsible for identifying and escalating issues and risks related to the clinical trial
- Ensures quality in clinical trial delivery by defining and executing quality control steps, including study quality and performance metrics and reporting
- Informs and manages stakeholders with appropriate clinical trial information
- Ensures submission and approval by relevant Ethics Committee(s) and other local bodies (except clinical trial application(s))
- Oversee clinical monitoring activities (approval of trip reports, plans etc.) and ensure compliance with applicable regulations
- Co-monitors, as needed to ensure sponsor oversight
- Defines Trial Master File Strategy (TMF) and oversees and manages execution of the TMF; understands importance of, and can lead, inspection readiness activities – including audit plans and processes
- Collaborates cross-functionally to support activities related regulatory filings and other relevant documents
- Responsible for coordination of data review activities required of Clinical Operations team members
- Manages protocol deviation reviews, including preventative action planning, immediate escalation of significant concerns
- Provides clinical supply projections and approves clinical supply demand
- Leads project team meetings and motivates the cross-functional team members
- Provides guidance and mentoring to project team members
- Demonstrates a focus on operational efficiency and identifies and communicates inefficiencies with proposed solutions; leads small to mid-sized process improvement efforts
- Contributes to the development of study protocols and understands study protocol objectives, key elements and endpoints in the context of the overall product or molecule strategy
- Contributes to the design and development of clinical systems supporting the trial, including overseeing user acceptance testing for Clinical Operations
- Leads development of clinical trial-related documents, including approving and maintaining study plans
- Conducts study feasibility and ensures proper site selection and setup
- Manages and drives processes for outsourcing to CROs and other third-party vendor(s), additionally serves as the primary project contract for communication and coordination for uniQure
- Interact frequently with external partners, including expert panels, physicians and investigators, CROs, contract laboratories, advisory committees, clinical trial consultants, and where appropriate, cross-functional counterparts from development partner(s)
- Bachelor’s degree in life sciences required; science/medical related degree preferred
- Minimum of 8 years of clinical trial coordination/management/operations experience in a clinical development environment within a CRO or sponsor company; CRA experience preferred
- Experience in and knowledge of conducting international clinical trials
- Demonstrates excellent understanding and application of ICH/GCP guidelines, including knowing which guidelines apply to the current study phase and work, understands the implications of not following GCP/ICH guidelines, and is adept at recognizing a breach. Also demonstrates awareness and understanding of interdependencies of other GxP regulations
- Experience in complex clinical research projects and early drug development is highly desirable, particularly within an orphan/rare disease therapeutic area
- Understands and applies knowledge of country-specific regulations and guidelines required for trial execution
- Demonstrates advanced ability to use core productivity software, collaboration and clinical systems to execute trial activities, and able to identify opportunities to improve systems to increase operational efficiency
- Demonstrated leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building skills
- Detail and process-oriented, with excellent project management skills, including risk assessment and timeline and contingency planning
- Prior experience in the financial and/or budget and forecasting management of clinical trials is preferred
- Proven excellence in cross-functional matrix and/or cross-cultural partnership setting, adept at working across different functional areas to raise and manage issues and risks to trial safety, quality, timelines, scope or budget
- Operates with a patient-centric mindset, embedding patient focused practices into day-to-day activities
- Excellent written, oral communication and presentation skills
- Strong interpersonal and communication skills, diplomatic in challenging situations
- Ability to travel up to 25%
- Enthusiastic and proactive, with a can-do attitude
- Organized, with attention to detail and sound problem-solving skills; aware of the sensitive and confidential nature of information and/or situation; able to think creatively to provide innovative solutions to (non-)standard problems
- Thrives working in a fast-paced environment and able to manage competing tasks and demands with a sense of urgency, comfortable dealing with ambiguity