上海招聘

职位描述：
? 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.


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:
? Experience as a SCRA


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 is preferred.
? Local project coordination and/or project management experience.
? Thorough knowledge of Covance SOPs regarding site monitoring. 举报 分享

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