Clinical Data Manager III (CDM III)
Caidya
Full time- 5+ years
- Not Disclosed
- Kolkata, India
- Post Date: Mar 06, 2024
- End Date: May 06, 2024
- 5+ years
- Not Disclosed
- Kolkata, India
- Post Date:Mar 06, 2024
- End Date: May 06, 2024
Skills:
- clinical research
- Operations
- Management
Job Description:
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
Qualification & Experience
-
- College graduate with a degree in life science, computing or nursing qualifications preferred; or 5 to 6 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
-
Salary
Not Disclosed
-
Role
Manager
-
Area of Practice
- Clinical Data Management
-
Experience
5+ years
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