Covance Clinical Team Lead, Belgium in Brussels, Belgium
The CTL is a member of the Local Study Team and has overall responsibility and accountability for the execution of the clinical operations strategy of the project.
The CTL is responsible for coordinating and managing the CRAs, providing operational leadership and expertise to ensure successful execution of the clinical operations project deliverables (quality, timeline, budget and scope).
This role involves regular and proactive communication with the Client Project Manager and other functional groups, as appropriate. The CTL will serve as the main site monitoring and site management contact and support for the Project Manager and CRAs.
Initiation and Planning:
Sets the project related clinical operations objectives and strategy in collaboration with the ProjectTeam
Provide input into the development of feasibility materials and recruits potential investigators. Responsible for the final site list
Requests, manages and tracks clinical project resource needs
Provides clinical operations input into cross functional project plans
Manages the successful design, implementation, tracking and revision of the monitoring plan and clinical operation training plans for assigned projects
Provides clinical support for regulatory submissions and IRB/ERC queries
Owns the development of project-specific site and monitoring tools
Responsible and accountable for management of the Clinical Operations team with particular emphasis on teamwork, quality and compliance with the project plans
Responsible and accountable for the clinical operations budget for the project. Ensures that clinical operations activities are within budget and scope
Responsible for managing the clinical operations timelines as agreed
Participate in internal project review meetings and provides clinical operations updates to the project management team
Ensures that all clinical operations staff allocated to assigned projects adhere to professional standards and SOPs
Ensures appropriate utilization of all assigned clinical operations team members
Responsible for timely and appropriate communication to the clinical operations team
Ensure accurate and timely trip report completion and trip report review
Follow project issue escalation process
Responsible for clinical operations Corrective and Preventative Action plans
Monitor and Control:
Track project metrics related to the clinical operations deliverables
Coordinate activities and review progress of the clinical operations aspect of projects and initiate appropriate actions to achieve target objectives
Ensures all site issues have been resolved
Ensures clinical operations sections of the TMF are complete
Education / Qualifications
University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
Proven relevant clinical research experience with an ability to demonstrate comprehensive understanding of:
Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Site monitoring and study site management requirements
Applicable regional regulatory requirements
Trip report review, risk planning, study plan development, resource planning and data management oversight
Additional requirements include:
Demonstrated ability to work with minimal supervision
Demonstrated good planning and organization skills
Good computer skills with good working knowledge of a range of computer packages
Demonstrated effective and professional verbal and written communication skills
Ability to train, lead and develop junior staff
Ability to understand and work with financial information
Ability to resolve project-related problems and prioritizes workload for self and team
Ability to work collaboratively within a project team
Ability to work efficiently and effectively in a matrix environment.
Job Number 2018-18779
Job Category Clinical Operations
Position Type Full-Time
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