Clinical Data Manager II - Cadiya
About the job
Job Title: Clinical Data Manager II (CDM II)
Job Location: Home-based
Job Overview:
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 Caiya 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:
- 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 Caidya 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 4 years equivalent experience.
- Experience
- Minimum of 2 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
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