Job Description :

Hi,

Position: Clinical Data Manager

Location: Remote

Rate: negotiable based on the experience

Primary Responsibilities:

  • PDM/Snr PDM customer facing level
  • 4-6 years experience leading studies
  • Strong communication skills
  • Organizational skills
  • Medidata Rave experience
  • Oncology or Infectious Disease experience
  • Performing all data management deliverables for assigned studies
  • Attending and participating in client meetings as requested
  • Ensures the plan for data management is properly executed by:
  • Understanding the requirements for study implementation and data collection
  • Collaborating with project team to develop study-specific edit check criteria
  • Defining, running, and reviewing edit checks and resolving discrepant data
  • Maintaining organized, complete, and up-to-date study documentation
  • Performing study setup, including TF design, database structure, specifications, and obtaining and providing approvals as needed
  • Coordinating and documenting the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from other central laboratories, CRO's, or Sponsors).
  • Keeping supervisor informed of project status
  • Ensures the accuracy and consistency of clinical databases by:
  • Reviewing data and identifying errors/inconsistencies
  • Collaborating with appropriate project team to resolve data issues
  • Tracking outstanding issues and following-up until resolution
  • Ensuring accuracy in manipulation and scrutiny of clinical data and that CDM activities are carried out according to regulatory guidelines
  • Maintains Quality Service and Departmental Standards by:
  • Adhering to all Clinical Data Management (CDM) procedures, policies, and work instructions
  • Reading, understanding and adhering to applicable Standard Operating Procedures (SOPs)
  • Assisting in establishing and enforcing departmental standards
  • Participating in the review and updating of company SOPs related to DM Services

Education:

  • Bachelor's degree in Computer Science, Life Sciences or related field preferred, or equivalent experience required
 ,
Raj
             

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