30 may
|
Cytel
|
Colombia
Postúlate en Kit Empleo: kitempleo.com.co/empleo/1b2mlg
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
Postúlate en Kit Empleo: kitempleo.com.co/empleo/1b2mlg
📌 Senior Clinical Data Manager (Medellín) (Colombia)
🏢 Cytel
📍 Colombia