Job Description

Due to recent business success, Covance is seeking a Senior Project Coordinator to join the Clinical Pharmacology Team within the European Centre of Excellence in the heart of Leeds, West Yorkshire. Your new position will be supporting Project Managers focused on Early Phase studies.

Your responsibilities will include but not be restricted to:

• Independently owns, creates and maintains study specific documents (e.g., Project Management Plan, Communication Plan, Risk Register, Project Specific Training Matrix and any other applicable plans as required), including compliance with client-specific requirements, for studies of varying complexity including external site studies. Distributes them to the study team and/or sponsor for review, compiles comments, and routes final documents. Independently monitors training compliance of the study team and updates the training matrix as required.
• Maintains an internal standardized filing structure for study related documents; proactively maintains documents within the filing structure, and suggests changes as necessary to maintain organized files.
• Independently uses and develops trial management tools to monitor study activity and perform tasks, including project setup activities (e.g., study ID request, SAS Environment Setup request, Study-specific Distribution Lists, etc.).
• Manages the setup and updating of CTMS; maintains knowledge and project expertise for CTMS reporting, study metrics, risk management regarding communication, coordination and eTMF quality.
• Independently organizes and attends applicable study-related meetings; generates and distributes agendas, maintains and distributes meeting minutes, independently sets up and maintains the Project Log, Risk Register, and study team contact lists; monitors/takes action on follow-up items from meetings; will facilitate client meetings including external site meetings in the absence of the PM; reviews documents for completeness and quality to reduce PM review time; participates in client visits as needed.
• Proactively posts documents such as CRA reports, project deliverables, trackers, regulatory documents, metrics, agendas, and minutes to client websites after completing administrator and program training on the client system.
• Develops, implements, and participates in business improvements initiatives to drive quality, productivity, and continuous improvements across different business units; offers ideas and suggestions to the PM or management on operational and logistical challenges and resolutions.
• Serves as direct sponsor and site contact in the absence of the PM, even during critical phases of varying complexity single and multi-site trials, may have limited authority to act in lieu of the PM, if needed.
• Manages payment process per global finance standards.
• Sets up, coordinates and maintains sponsor/internal training in accordance with applicable SOPs and processes.
• Oversees training and mentoring of other PCs; independently trains/mentors any department staff, including PMs, on tasks/processes/areas in areas of expertise; responsible for routine development/review/revision of PC training materials; maintains subject matter expertise in all aspects of the TMF.
• Coordinates and manages support across large global studies. Drives efficiency and quality in coordination activities and applicability to clinical trial management.
• Provides support with reviewing and managing all aspects of assigned projects (financials, enrolment, vendors etc.).
• Independently oversees the development of protocol tools as required for the project (e.g., screening and enrolment log and development of investigator training).
• Independently oversees feasibility site start up activities including feasibility, providing sites with feasibility questionnaires and protocol as required, collating the information from the site into the appropriate tracking document.
• Acts as the primary point of contact for external sites during study maintenance, responding to queries, providing documents.
• Independently maintains overall project trackers, including financial, screening, and vendors.
• Independently creates work scope changes as they relate to changes in the sponsor contract.
• Independently liaises with vendor services, such as clinical laboratories, translation services, equipment suppliers and appropriate functions within Covance to support a project (e.g., QA, Client Services, Finance teams). Education/Qualifications:

Required Knowledge, Skills, and Abilities

To be a successful applicant considered for this position, you will hold a degree or equivalent qualification in a scientific discipline and will have worked within the clinical trials operations field. You will have pharmacology experience and exposure to Phase I clinical trials. Experience: Minimum Requirements: Knowledge of the clinical trial process with early clinical pharmacology experience preferred Substantial experience in a research environment Recent and relevant experience working in a project management environment. Knowledge of protocol designs, study objectives, study procedures, and project-related timelines Advanced knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guideline.