Job Description
JOB DESCRIPTION JOB RESPONSIBILITIES: - Adherence to SOPs and maintaining audit-ready documentation.
- Coordinate and oversee activities of all DM staff assigned to the project, ensuring high quality, respecting project timelines and adherence to the budget.
- Attend relevant project meetings and work closely with other internal and external leads.
- Liaise with client/partners for clarification on any clinical and / or technical decisions and propose most efficient solutions.
- Identify risks to project deliverables and timelines, develop and implement the mitigations for these risks.
- Create DM timelines for database set-up.
- Lead and participate in the design of Clinical Electronic Data Capture (EDC) components including mock CRF, casebook, edit checks.
- Coordinate and create data management documentation including Data Management
- Plan, Data Validations Specifications, eCRF Completion Guidelines, Data Collection 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 reconciliation.
- Provide input to protocol and assess database impacts based on protocol changes during study lifecycle; prepare and execute change request forms.
- Lead and participate in Database Lock activities, including timelines creation, QC coordination and Data Management Report creation.
- Contribute to departmental procedures and guidelines.
- Critically evaluate data management needs and propose appropriate, innovative, and efficient data management solutions.
- 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 Management representative during bid-defense, as needed.
- Support senior team members and/ or be the data management representative during audits.
- May act as a line manager, contribute to the development of a strong team of data managers, by functionally managing and guiding the data managers with respect to data management strategy, deliverables, processes, and professional development.
Job Tags
Permanent employment,