Hybrid Sr. Data Manager or Principal Data Manager Sr. Data Manager or Principal Data Manager with verification
Cytel · nan, · Hybrid
About the job
through database lock, including database set-up and data validation as per the requirements
in the clinical protocols and ensure timely delivery of high-quality consistent data. Lead all
portions of a project/and or multiple projects with minimal or no supervision.
Job Responsibilities
- Adherence to SOPs and maintaining audit-ready documentation.
- Coordinate and oversee activities of all DM staff assigned to the project, ensuring
- Attend relevant project meetings and work closely with other internal and external
- Liaise with client/partners for clarification on any clinical and / or technical decisions
- Identify risks to project deliverables and timelines, develop and implement the
- Create DM timelines for database set-up.
- Lead and participate in the design of Clinical Electronic Data Capture (EDC)
- Coordinate and create data management documentation including Data Management
System Configuration, Data Transfer Agreement.
- Coordinate and perform User Acceptance Testing.
- Train EDC users.
- Manage EDC users’ access and assist with resolving issues.
- Coordinate all conduct Data Management tasks.
- Lead and participate in data cleaning activities including SAE and external data
- Provide input to protocol and assess database impacts based on protocol changes
- Lead and participate in Database Lock activities, including timelines creation, QC
- Contribute to departmental procedures and guidelines.
- Critically evaluate data management needs and propose appropriate, innovative, and
- Train and mentor less experienced staff.
- Represent Cytel at project, proposal, or industry meetings.
- May participate in the recruitment process.
- Contribute to budget evaluation for proposal writing purpose and be Data
- Support senior team members and/ or be the data management representative
- May act as a line manager, contribute to the development of a strong team of data
data management strategy, deliverables, processes, and professional development.