Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Clinical Data Manager you will be dedicated to one of our integral pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Responsibilities

- Lead or support data management study activities, CRO oversight, and driving deliverable timelines.
- Strong knowledge of EDC builds.
- Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and client for all data related deliverables, especially in support of key decision points and regulatory submissions.
- Contributes influential leadership in collaboration with other client Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.




- Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
- Provides input to functional governance with client strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
- Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
- Participates and represents function in formal inspections and audits as requested.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
- Responsible for the planning and management of external Data Management budgets and timelines to

📌 Senior Clinical Data Manager (Colombia)
🏢 Cytel
📍 Colombia