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Clinical Team Leader - South East UK

Covance 9/24/2018 12:31:33 PM
JOB ID: 24164 Category: Clinical Trial Management
Maidenhead, United Kingdom

   

 

Job Overview

Covance is recruiting an office based Clinical Project Leader to join a global Pharmaceutical company in the South East of England. Therapy areas will include Diabetes. Oncology, Cardiology and Neurology.

Commercial Responsibilities

* Contribute to the operational plan and participate in the delivery of Bid Defense presentations for new business, as required.
* Develop and maintain relationships with assigned clients and serve as the client interface for all clinical operations matters. Meet/exceed client satisfaction expectations.
* Initiation and Planning
* Sets the project related clinical operations objectives and strategy in collaboration with the Core Team.
* 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.
* Develops the risk and contingency plans for key clinical operations activities in collaboration with the Core Team.
* Manages the successful design, implementation, tracking and revision of the monitoring plan and clinical operation training plans for assigned projects.
* Writes the prototype informed consent form.
* Provides clinical support to Global Site Services for regulatory submissions and IRB/ERC queries.
* Assists in the design of the CRF, EDC or equivalent.
* Owns the development of project-specific site and monitoring tools.
* Owns the development of training materials and training specific to the clinical operations team.
* Develops and presents the clinical operations training materials for Investigator Meetings.

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 with the client.
* Participate in internal project review meetings and provides clinical operations updates to the project management team.
* Responsible for the clinical management of approved sub-CROs. May also be requested to manage approved vendors for clinical activities or services.
* 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.
* Provide performance feedback of team members to respective supervisors.
* Ensure accurate and timely trip report completion and trip report review.
* Review and approve investigator grant payments
* Follow project issue escalation process and Covance's Corrective Action Issue Resolution (CAIR) process for clinical operations issues.
* Responsible for clinical operations Corrective and Preventative Action plans.
* Performs co-monitoring visits when necessary.
* Ensure timely filing of relevant sections of the TMF. Monitor and Control
* Track client project metrics related to the clinical operations deliverables.

* Owns and implements the risk and contingency plans for key clinical operations activities.
* Coordinate activities and review progress of the clinical operations aspect of projects and initiate appropriate actions to achieve target objectives.
* Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects
* Track project progress against financial milestones using applicable financial systems. Review Time Analysis and provide monthly hours forecast.Close-Out
* Consolidates resources to ensure financial viability during close-out.
* Ensures all site issues have been resolved.
* Ensures clinical operations sections of the TMF are complete.
* Coordinates archival of the clinical operations sections of the TMF.

Education / Qualifications

Required:

* 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.
* In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research Experience in pharmaceutical, CRO industries or Experience in a health care setting will be considered.
* Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
* Thorough understanding of the drug development process.

Preferred:

* Working knowledge of Covance SOPs.
* Experience as a Senior Clinical Research Associate, whether internal or external.

Experience

Required:

* Minimum of five (5) years of 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.

* In lieu of the above requirements, candidates with > two (2) years supervisory Experience in a health care setting and four (4) years clinical research Experience (including monitoring) in the pharmaceutical or CRO industries will be considered.
* 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.

Preferred:

* 1+ years additional Experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.

* Local project coordination and/or project management Experience .
* Thorough knowledge of Covance SOPs regarding site monitoring.


Position Type: Full-Time

Location: Maidenhead, UK - United Kingdom



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Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).