南京招聘

Position Summary
Responsible for ensuring the completeness, timeliness, quality and integrity of the Clinical Trial data.
Ensure data quality and consistency per applicable regulatory requirements, SOP(s), Processes and data standards. Works with the project team to meet the study objectives. May lead data management projects and act as the go-to-person or point of contact.

任职要求：
Key Responsibilities
General
? Ensure that all data management activities are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.
? Ensures Conformance to CDISC standard.
? Actively participates in project team meetings.
? Continuous learn clinical development knowledge and data management related skills and knowledge
Hands-on data management responsibilities (Data Manager):
? Ensure timely set-up of data collection mechanisms per CDISC or applicable data standards.
? Create and implement the Data Management Plans (DMP) to ensure data completeness and accuracy.
? Perform and ensure quality and timeliness of data management activities as specified in DMP.
? Perform data cleaning activities including discrepancy management and review of data listings to verify quality and completeness of data.
? Ensure integrity of clinical data and update database by issuing and resolving queries as necessary.
? Reconcile the patient database with the Serious Adverse Event database.
? Document all efforts of data management and file all responsible documents.
Project management responsibilities (Lead Data Manager):
? The single point of contact for project team on data management
? Review protocols to ensure the data collection, database and reporting requirements can be met and are standardized
? Accountable for the implementation of all data activities for the responsible studies.
? Provide oversight, guidance and coordination for all the data management activities, as well as coordinate project team and resources
? Produce and track metrics as a tool to ensure that data management deliverables are on target.
? Conduct quality control processes, coach and guide new or junior staff
? Ensure clear and timely communication with project team to enable trial delivery.
dMed Internal Use
HR01-SOP-TP01, Effective 03-Mar-2017 Page 2 of 2
? Proactively plan, assess workload, and prioritize activities to ensure study timelines are met
? Be the go-to-person for project specifics, or data management functional process and key steps
? May be responsible to review and confirm project member activity tracking, resource utilization, and monitor key milestone delivery
? May support bidding meeting upon request
Education and Key Competency Requirements
Professional Experience & Education Requirement
? Degrees in life science, such as medical, pharmacology, biological, etc.
? For Specialist / Sr Specialist, at least 2+ years experience in clinical data management, clinical trial operation or related functions
? For Project Manager / Manager, no less than 5 years experience in clinical data management, clinical trial operation or related functions, plus at least 2 years project leadership experience.
Key Competency Requirement
? Knowledge of GCP and regulatory requirements of clinical trials
? Knowledge of data management activities and processes
? Work independently, receives instruction primarily on unusual situations
? Strong customer service orientation
? Effective plan and organize work for delivery within timeline, and able to prioritize to manage of multi-tasks
? Attention to details with high quality standards
? Communicate effectively and appropriately with internal & external team including vendors and clients
? Work with project teams to identify and articulate complex problems
? Effective interpersonal skills and collaborative team player
? Effective project management skills

备注： ‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。

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创始人及部分核心专业领域


创始人 - 谭凌实博士：拥有20多年跨国一流制药公司总部高级管理经验。此前担任辉瑞公司全球药物开发运营副总裁，在中国成功创建了首屈一指的研发中心，且经历10多年发展壮大到多个地点，成为辉瑞全球核心的研发中心之一，承担药物临床开发、安全风险管理、注册、临床稽查等关键职能。谭博士多年为RDPAD, DIA 的核心成员，担任重要职务,包括研发委员会主席, 全球董事等。谭博士还带头建立了与国内一流高校的教育培训合作，比如复旦大学、北京大学，交通大学。培养了不少拥有专业技能和行业知识的临床数据管理和编程人才。谭博士有在美国建立初创企业的经验，且在美国一流制药企业研发中心工作多年。谭博士拥有生物统计博士学位。