BriefCase
BriefCase

Clinical Data Manager Iii (cdm Iii) Job in Clinipace

Clinical Data Manager Iii (cdm Iii)

Clinipace 4+ weeks ago
Apply Now
Job Summary
  • For specified projects performs start-up activities including:
    • Developing data management guidelines and study documentation
    • Review of CRF design against protocol
    • Lead study developing core study documents for data management including DMP, DVP, CRF completion guidelines, and other study documentation. Activities include design, database structure, document creation; including approval
  • For specified projects performs 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
    • Review of data listings
    • Identification of data issues and query generation
    • Updating of database with query resolutions (paper studies only)
    • Processing and reconciliation of external data including SAE reconciliation
    • 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
    • If assigned the Lead Data Manager role, act as key data management contact for the project.
  • Awareness of the CAPA process and provide input for audit responses regarding assigned tasks
  • Proactively manage project quality through supervision and quality control of team members work.
  • Proactive participation in appropriate sponsor/project team meetings.
  • Active involvement in departmental and organizational meetings and initiatives.
  • Develops and documents departmental procedures.
  • Training and Mentoring of team members in accordance with established departmental procedures.
  • 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
  • Indirect supervision of the work of junior members of the project team.
  • Other duties as assigned
  • Education
    • College graduate with a degree in life science, computing or nursing qualifications preferred; or 3 to 4 years equivalent experience.
  • Experience
    • Minimum of 5years of experience and/or demonstrated aptitude for data management work. International team experience preferred.
    • Experience working in pharmaceutical and/or Contract Research Organization (CRO) industry preferred
    • Prior trial responsibility for entire data management life-cycle
    • Working knowledge of EDC studies
  • Skills/Competencies
    • Excellent organizational skills
    • Strong written and verbal communication skills
    • Exceptional attention to detail
    • Knowledge of clinical research including regulatory requirements GCP/ICH
    • Strong interpersonal skills; serve as the point of contact for data management activities
    • 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.
Experience Required :

3 to 4 Years

Vacancy :

2 - 4 Hires

Similar Jobs for you

See more recommended jobs