Covance Clinical Team Lead in Beijing, China

Job Overview

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.

The CTL may perform other tasks as assigned by the project team throughout the course of the project.

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

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.

Job Number 2018-20279

Job Category Clinical Operations

Position Type Full-Time

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