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Clinical Data Manager II (CDM II)

3.00 to 5.00 Years   Delhi   31 Mar, 2021
CLINIPACE WORLDWIDE
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

The Clinical Data Manager II participates in the clinical data management activities for a project within a data management project team; including processing of case report form (CRF) and electronic data in accordance with Clinipace SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements. Job Duties and Responsibilities:The specific job duties of a Clinical Data Manager II may include but are not limited to:

  • For specified projects performs start-up activities including:
    • Developing data management guidelines and study documentation
    • Assists in developing core study documents for data management including DMP, DVP, CRF completion guidelines, and other study documentation as needed
    • Review of CRF design against protocol
    • Review of database setup
  • For specified projects performs some data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.
    • Study status tracking and associated metrics
    • Data Entry
    • Review and reconciliation of data listings
    • Identification of data issues and query generation
    • Updating of database with query resolutions (paper studies only)
    • Ownership and proactive management of the data reconciliation activities documented in the DVP, DMP, etc.
    • Provide input for Database closeout and lock activities and timelines
    • Archiving of critical documents on an ongoing basis
  • Provide support to deliver DM specifications for CRF counts and associated details for proposal needs.
  • Awareness of the CAPA process and provide input for audit responses regarding assigned tasks
  • Participate in User Acceptance Testing for assigned projects
  • For specified projects performs study finalization activities including:
    • Database close-out
    • Critical item review and Quality control support as needed, per platform
    • Data review and reconciliation
    • Quality Control
    • Archiving
  • Supports and tracks budget adherence in cooperation with Finance to ensure the assigned studies are meeting targeted margins and utilization
  • Continuous improvement of departmental processes and procedures to ensure DM is consistently maximizing efficiencies, leveraging technology and incorporating innovation to optimize delivery
  • Maintains working knowledge of regulatory requirements/guidance as well as industry leading best practices to ensure Clinipace DM procedures are in line with industry expectations
  • Other duties as assigned
Supervisory Responsibilities:No supervisory responsibilities.Job Requirements:
  • Education
    • College graduate with a life science, computing or nursing qualification or 3 to 5 years equivalent experience.
  • Experience
    • Minimum of 4 years of experience with demonstrated experience supporting data management work.
    • Experience working in pharmaceutical and/or Contract Research Organization (CRO) industry preferred
    • Working knowledge of EDC studies
  • Skills/Competencies
    • Strong organizational skills
    • Strong written and verbal communication skills
    • Exceptional attention to detail
    • Knowledge of clinical research including regulatory requirements GCP/ICH
    • Strong computer skills, including Microsoft Office and clinical data management systems
    • Demonstrated problem-solving skills
  • Capabilities
    • Flexibility - willing to change assignments and work focus to accommodate project demands
    • Team player effective proactive participant as a team member
    • Dedicated home office environment for home-based employees, as applicable
,

Keyskills :
data managementclinical trialscustomer relationsdatabase administrationoncologyuser acceptance testinggood clinical practiceclinical data management

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