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Position Title:Data Management Specialist/Senior Specialist
Department:Clinical Data Management
Location:Shanghai

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), and data standards. Work 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.

Key Responsibilities

General:

  • Ensure that all data management activities are conducted in compliance with GCP, SOPs, and regulatory requirements. And ensures conformance to CDISC standard.
  • Actively participates in project team meetings, and continuously develop relevant knowledge and skills
  • Data management responsibilities (Data Manager):

  • Set-up of data collection mechanisms per CDISC or data standards.
  • Create and implement the Data Management Plans (DMP), and perform data cleaning activities
  • 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.
  • Project management responsibilities (Lead Data Manager):

  • Act as point of contact for project team on data management, ensure clearly and timely communication for project progress and delivery
  • Review protocols to ensure data collection, database and reporting requirements can be met and are standardized
  • Provide oversight, guidance and coordination for data management activities, coordinate project team and resources
  • Produce and track metrics to ensure data management deliverables are on target.
  • Conduct quality control processes
  • coach and guide new or junior staff
  • Proactively plan, assess workload, and prioritize activities to ensure timelines are met
  • Be the go-to-person for project specifics, or data management functional process
  • Support bidding meeting per request

  • Education and Key Competency Requirement
    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
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