Clinical Data Manager II

1w1 week ago

Allucent

Chennai, IN · Full-time · INR 1,200,000 – INR 2,200,000

About this role

Support DM-related activities and collaborate with Lead DMs, Clinical Programmers, Data Scientists, Clinical Monitoring teams, and other functions like Project Management, Clinical Operations, and Biostatistics. Provide regular updates to Lead DM on progress, timelines, risks, and quality. Support resource planning when assigned as Lead CDM.

Develop, review, and maintain key DM documents such as DMP, eCRF specifications, DVP, and external data transfer agreements. Support or lead clinical database setup, including eCRF design and validation requirements. Participate in reviewing study documents like protocols, project plans, safety plans, and statistical analysis plans.

Coordinate and complete User Acceptance Testing (UAT) activities for databases. Track tasks against budget and forecasts, identifying scope change requests when required. Participate in meetings with vendors and sponsors as needed, while identifying issues and solving problems.

Create training materials and provide EDC training for study teams. Contribute to process improvement initiatives to enhance efficiency. Support alignment of data management and clinical programming standards and best practices.

Requirements

Create training materials and provide EDC training for study teams
Review and validate clinical data for accuracy, consistency, integrity, and completeness
Support data cleaning strategies and assist in data releases including interim and final locks
Perform data transfers and reconciliation activities for SAE, PK, lab data
Prepare project metrics and status reports on site performance, data trends, protocol deviations
Conduct Quality Review activities and support database maintenance, lock, and close-out
Maintain up-to-date DM documentation and prepare for audits
Identify issues, solve problems, and assess effectiveness of solutions

Responsibilities

Support DM-related activities and collaborate with Lead DMs, Clinical Programmers, Data Scientists, and cross-functional teams
Provide regular updates to Lead DM on progress, timelines, risks, and quality
Develop, review, and maintain key DM documents such as DMP, eCRF specifications, DVP, and external data transfer agreements
Support or lead clinical database setup, including eCRF design and validation requirements
Coordinate and complete User Acceptance Testing (UAT) activities for databases
Review and validate clinical data to ensure accuracy, consistency, integrity, and completeness
Perform and coordinate data transfers and reconciliation activities for SAE, PK, lab data
Prepare and review project metrics and status reports, highlighting site performance and data trends

Benefits

Departmental Study/Training Budget for professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid working depending on location
Leadership and mentoring opportunities
Participation in Buddy Program
Internal growth opportunities and career progression
Access to online soft-skills and technical training via GoodHabitz and internal platforms
Eligibility for Spot Bonus Award Program and Loyalty Award Program