宜昌招聘

JOB TITLE: Clinical Trial Management Assistant (CTMA)

DEPARTMENT: China Medical

JOB TITLE SUPERVISOR: Sen. Manager, Clinical Trial Management


PURPOSE OF THE JOB
The Clinical Trials Management Assistant (CTMA) provides support to the Asia Pacific Clinical Project Management Organization in the management of clinical trial planning and implementation in order to ensure on-time and on-budget fulfillment of deliverables. The assistant supports trial-Ievel, project level and non-trial specific tasks within the assigned team.

CORE JOB RESPONSIBILITIES
CLINICAL TRIAL EXCUSION
? Tracks clinical trial issues and brings issues to the attention of the Global Clinical Trial Management (CTM) Associate.
? Assists in the facilitation of the Study Development Process. May manage issues and Decisions Log throughout the course of the trial.
? Assists in the management of study budgets,invoicing,purchase orders,and e-requisitions.
? Assists in the management of data throughout study and during datalock by working with CRAs to resolve outstanding CRFs/queries.
? Assists in the production,QC,and/or validation of the Clinical Study Report or other regulatory documents.
? Monitors trigger points from risk identification plans.
? Orders,tracks and ships study supplies, tools, videotapes,and instruments.
? Assists in the development and implementation of trial communications (e.g., teleconferences, newsletters) to keep the study team and trial sites abreast of trial.
? Information (e.g., timeline changes).
? Assists in the development of training tools for the affiliates and investigator sites.
? Tracks and reports enrollment data for ongoing clinical studies.

CLINICAL TRIAL DOCUMENTATION
? Coordinates, reviews, and tracks clinical trial information to meet regulatory documentation requirements.
? Assists in understanding and obtaining required documentation when working with a Contract Research Organization (CRO).
? Coordinates and oversees maintenance and inspection readiness of study files.
? Assists with coordinating contractual agreements (vendors,consultants,C ROs,etc.).
? Maintains oversight of filing and archiving processes for the team.

DATABASE MAINTAINANCE
? Maintains project plans and tracks project milestone dates to business metrics.
? Assists in producing project status reports.
? Assists in the maintenance of business planning databases.
? Inputs study timelines and other required data into the clinical trial database,monitors and updates fields as study timelines or other information changes,troubleshoots illogical data.
? Prepares Ad Hoc reports from the clinical trial database.
? Develops and maintains project team rosters and email distribution lists.
? Assists with the IVRS, e-CTS, Inform, and other supportive system set-up processes.

COMMUNICATION
? Assists in the coordination of affiliate and functional area communication.
? Communicates with consultants, C ROs, and other external vendors.
? Disseminates clinical trial updates, as appropriate.
? Documents, tracks, and assists in the resolution of clinical trial issues.

MEETING MANAGEMENT
? Assists with the coordination of project- related meetings.
? Composes and distributes meeting agendas and minutes, as appropriate.
? Assists with or facilitates the coordination of Affiliate Training, Start-up and Investigator, Meetings, and virtual training methods.

MINIMUM REQUIREMENTS
? Two-year degree or equivalent work experience.
? Computer proficiency is required. Experience with using a variety of software packages (e.g., Microsoft Word, Excel, Power Point, Project); knowledge of clinical trial databases, trial dashboards and business metrics.
? Strong communication skills (verbal and written).
? Strong attention to detail.
? Excellent teamwork and interpersonal skills.
? Strong self-management and organizational skills.
? Ability to maintain confidentiality.
? Strong customer service skills.

PREFERENCES
? Strong self-management and organizational skills; able to manage workload,set personal and team priorities and adjust as needed.
? Able to anticipate change,shows flexibility, adjusts quickly and effectively to frequent change and altered priorities.
? Strong computer skills; skilled at using Word, Excel, PowerPoint, ProChain and Microsoft Project; capable of maintaining the appropriate project documentation.
? Strong problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes and take actions to prevent recurrence within the team.
? Strong communication skills; able to communicate clearly and succinctly with team members and leadership.
? Ability to influence others without direct authority.

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礼来于1918年来到中国，将其第一个海外代表处设在上海。在1993年重新回到中国。已成为业界增长速度最快的制药公司之一。至今，我们在苏州拥有一家独资企业：礼来苏州制药有限公司，30多家办事处，员工已超过1400人。 礼来全球研发中国总部也于2008年10月15日在上海张江高科技园区正式成立。

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