Job Title: Clinical Data Manager III (CDM III)
Job Location: India (Remote)
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.
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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
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- 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.
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