Senior Clinical Project Operations Specialist

Senior Clinical Project Operations Specialist

Location:
Lexington, MA
Education level:
Bachelor / Graduate

Job category:
Clinical Operations
Target start date:
5/1/2025

Work Location:
Hybrid
Shift:
1st

Place in the Organization

The Senior Clinical Projects Operations Specialist (Senior CPOS) is responsible to support the study CTM and/or COPL of one or more projects across uniQure portfolio. The main mission of the Senior CPOS is to support internal facing compliance related tasks. Such tasks are aimed to increase uniQure clinical studies inspection readiness level. This position requires a proactive, hands-on mindset and ability to operate independently with minimal instruction on daily tasks.

Key result areas (major duties, accountabilities and responsibilities)

• Responsible for maintaining the uniQure study team roaster, inform internal & external team members of changes, and manage internal & external system access accordingly.
• Support the CTM with the creation and maintenance of the study specific training matrix. Coordination and tracking of all study-level training for internal personnel as per the study specific training matrix, as well as any uniQure trainings provided to vendors and sites
• Trial Master File (TMF) subject matter expertise:
  • Supports inspection readiness of the TMF of the assigned study/studies.
  • Responsible for coordinating the internally facing TMF component set-up, maintenance, QC and close-out.
  • Acts as a subject matter expert in TMF Plan development/revisions.
  • Responsible for providing (or facilitating) TMF training to and managing system access for uniQure document owners.
  • Works with cross functional document owners and supports/coordinates the filing of uniQure owned clinical trial documents into the TMF.
  • Performs CO quality control (QC) reviews and works with cross functional document owners to ensure cross functional TMF QC (periodic and final).
  • Communicates TMF QC findings to the TMF management vendor and works to resolve QC findings.
• Support the set-up, tracking and managing of study logistics (i.e., lab sample traceability, system access, supplies, study document annual renewal dates, etc.) and support other study administrative tasks as needed.
• Support the review and updates of clinical trials related SOPs and WIs and other process improvement initiatives

#LI-EB1

• Minimum of 5 years relevant work experience at a clinical site, CRO, Sponsor, or clinical-type vendor
• Ability to interact with diverse internal and external stakeholders and navigate complex business environments.
• Ability to work with multiple project teams, prioritize tasks and effectively contribute to the project's inspection readiness at all times.
• Demonstrates understanding of the end-to-end clinical trials set up for the assigned studies, including protocol objectives and operational impacts
• Understanding of the responsibilities and needs of other functions in a clinical trial
• Demonstrates understanding of the importance of SOPs and associated documents and how they apply to an individual's role/work
• Understanding of current ICH-GCP regulations, guidelines. Understanding of local or country-specific regulations.
• Computer skills: Intermediate level, recent and active knowledge of MS Office applications, able to support study or project documentation using core productivity software, and able to utilize core collaboration and clinical systems for trial/project purposes
• Fluent in English, verbal and written