Covance Clinical Team Lead, Belgium in Brussels, Belgium

Job Overview

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

Execution:

  • 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

Close-Out:

  • 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.

Experience

Proven relevant clinical research experience with an ability to demonstrate comprehensive understanding of:

  • ICH/GCP guidelines

  • 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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