Job Overview:  

The Clinical Data Manager III is responsible to participate the clinical data management activities for a project within a data management team; including processing of Case Report form and electronic data, processing and reconciliation of external data, SAE reconciliation and supporting the database close/lock procedures in accordance with Caidya SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.  Work as a Project Point of Contact (POC), manage work allocation and work with minimal or no supervision.

 Job Duties and Responsibilities:

The specific job duties of a Clinical Data Manager III may include but are not limited to:

• 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 Caidya DM procedures are in line with industry expectations.
• Indirect supervision of the work of junior members of the project team.
• Other duties as assigned.

 Supervisory Responsibilities:

No supervisory responsibilities.

 Job Requirements:

• Education
  • College graduate with a degree in life science, computing or nursing qualifications preferred; or 3 to 4 years equivalent experience.
• Experience
  • Minimum of 5 years 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.