西安招聘

Associate Clinical Project Manager (China) [last update 7-2012]


Expected Areas of Competence/Responsibilities
? Participate in the design and development of clinical study protocols, case report forms, source documents, electronic data capture devices, and other regulatory documents (e.g., Informed Consent).
? In collaboration with Medical Affairs Directors (Director-China and Associate Director-China), plan and manage the operational aspects of clinical studies to ensure delivery of high quality results in a timely manner.
? In collaboration with Medical Affairs Directors, carry out investigator identification, selection, evaluation, initiation, and training.
? In collaboration with Medical Affairs Directors, carry out identification and selection of central laboratories when needed. Work with central laboratory in developing lab kits, training materials and manuals for the study.
? Coordinate internal and external protocol approval processes, including IRB/Ethics Board submission and approvals with guidance from the Medical Affairs Directors.
? Collaborate with contract clinical monitors to ensure monitoring efforts occur within an appropriate schedule and result in high quality data and receipt of data meets established timelines. Assist monitor in diplomatically resolving difficult issues at study sites along with the Medical Affairs Directors.
? Establish, maintain, and cultivate working relationships with investigators and their staff to project image and to enable high scientific standards and integrity.
? In collaboration with the Medical Affairs Directors, develop, negotiate and manage budgets for individual study sites.
? Collaborate with Medical Affairs Directors to resolve site related issues.
? Generate project documentation (including but not limited to) project specifications, project reports, communication records, and status reports.
? Update investigators and study staff on status of study and ensure that motivation and interest are maintained in the study.
? Proactively identify key issues in clinical trial execution and develop solutions to ensure delivery of project goals and timelines.
? Stay abreast of current developments in corporate, federal and international regulations and adjust internal procedures to ensure clinical study process is compliant.


Core Behaviors and Necessary Skills
? Solid leadership skills.
? Excellent communication and organizational skills. Ability to communicate and interact with a diverse audience within and outside the organization.
? Ability to identify deviations from project plan and to work with project team and management to develop corrective action plans.
? Ability to work in a team environment.
? Ability to anticipate problems relating to projects and to develop and implement solutions.
? Ability to understand and review detailed clinical reports.
? Knowledge of project management tools and practices.
? Ability to manage multiple projects at varying stages of completion, with a high level of accuracy and attention to detail.
? Effective in setting and meeting personal short- and long-term goals to complete assignments.


Qualifications and Experiences Desired
? Master, preferably in a scientific field, or equivalent knowledge gained through experience working in a scientific area.
? At least 4 years of clinical research experience, including field monitoring of clinical trials.
? Knowledge of International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines for clinical research.
? Experience working with a range of technically and culturally diverse people to accomplish project objectives within a tight timeline.
? Practical experience in clinical trial methodology, particularly study design and operational aspects.
? Thorough understanding of traditional CRA skills (site identification, monitoring, tracking, data collection and cleaning)
? Basic understanding of nursing and medical practices as they apply to nutritional clinical trials. Knowledge of medical terminology helpful.
? Strong information management skills, including proficiency with MS Office.

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