- Location:
-
Colombia
- Salary:
- Competitive
- Type:
- Permanent
- Main Industry:
- Search Information Technology Jobs
- Other Industries & Skills:
- Manufacturing, Media
- Advertiser:
- Cytel Inc
- Job ID:
- 132241599
- Company:
- Cytel Software Corporation
- Posted On:
- 06 September 2025
JOB SUMMARY: Coordinate and perform data management tasks from study start up
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
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.
