Senior Clinical Data Manager (Medellín) (Colombia)

Senior Clinical Data Manager (Medellín) (Colombia)

30 may
|
Cytel
|
Colombia

30 may

Cytel

Colombia

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.
- Represent 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.
- Contribute influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.




- Partner with appropriate stakeholders and CRO partners to mitigate and resolve risks.
- Provide input to functional governance with client strategic suppliers.

Resolve issues escalated from the vendor and/or cross‑functional teams.
- Participate in preparing function for submission readiness and may represent function in a formal inspection or audit.
- Represent function in formal inspections and audits as requested.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Ensure achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
- Take responsibility for planning and managing external Data Management budgets and timelines to ensure accuracy, understand trends in variances, and support continuous improvement in forecasting.
- Act as a process expert for operational and overs

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

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