替代专业:Chemistry, Natural Science, Biostatistics, or related field
可替代教育及经验组合:N
所需教育层级:
其他可替代教育层级:
认可经验年限:
境外教育背景:Y
可替代职业:Y
可替代职业时长（月）:96
可替代职业名称:Sr. Clinical Data Mang., Clinical Solutions Project Mang., Lead Clinical Data Mang., or rel occp.
是否为正常职业要求:N
是否需要外语:N
特殊技能:1.Applying drug development process including experience in early phase oncology clinical trials and response criteria such as RECIST.br 2.Training and managing staff internal, contract, and CRO to support the clinical data management team on projects and deliverables within the clinical data management function.br 3.Using electronic data capture EDC tools including Medidata Rave, Oracle Clinical, and Inform to perform clinical trials.br 4.Applying ICH and GCP guidelines to clinical data management.br 5.Leading or participating in the development, reviewing, and implementing processes, SOPs, and standard templates for clinical data management.br 6.Providing direction and leadership in CRO and vendor selection and management.br 7.Ensuring that CDM related documentation to support regulatory submissions and inspections are maintained to standard requirements.br 8.Leading and overseeing all data management activities for multiple clinical trials including designing case report forms and completing guidelines for eCRF, designing, and testing EDC systems, developing edit checks, developing data management plan, and developing data transfer agreements, SAE reconciliation, database freeze and lock activities.br 9.Participating in the generation and approval of budgets and timelines.br br Position requires up to 25 travel.br br Position permits telecommuting, applicant may reside anywhere in U.S. and report to Hayward, CA. Any incurred business travel will be fully reimbursed.br br Position supervises 1 Job title Manager, Clinical Data Management