Senior Clinical Data Manager

Cytel; Colombia; Presencial; COP 90.000.000 - 150.000.000; Jornada completa

Descripción de la vacante

Cytel seeks a Senior Clinical Data Manager to work embedded with a pharmaceutical client, supported by Cytel. You will lead data management activities, oversee CROs, and ensure data deliverables align with regulatory expectations across TMF and submissions.

With extensive experience in data management, you will contribute to governance, implement best practices, and coordinate with multiple stakeholders to maintain timelines and quality in global trials.

Formación

• Bachelor's Degree in a science, health related, or information technology field.
• Minimum 5 years experience in clinical data management.
• Strong knowledge of FDA and ICH regulations and industry standards in data capture and management.
• Experience with data management processes and CDISC/TMF practices.

Responsabilidades

• Lead or support data management study activities, CRO oversight, and drive deliverable timelines.
• Represent data management in the Clinical Sub-team to align CRO and client expectations for data deliverables, including regulatory submissions.
• Partner with stakeholders and CROs to mitigate risks and ensure milestones and deliverables are met with high quality.
• Maintain SOPs, process maps, and templates to support operations and governance.

Conocimientos

Data management

Leadership

Cross-functional collaboration

Regulatory knowledge (FDA/ICH)

Educación

Bachelor's Degree in Science/Health/IT

Herramientas

EDC builds

Descripción del empleo

Job Description

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 global 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.

Sponsor-dedicated

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 global 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 ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
• Acts as a process expert for operational and oversight models.
• Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
• May prepare metrics to support the function’s KPIs.
• Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of client.
• Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
• Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.

Qualifications

Bachelor's Degree in a science, health related, or information technology field required.

Minimum 5 Years Experience In Clinical Data Management

• Experience with all phases of development in one or more therapeutic areas preferred.
• Strong knowledge of data management best practices & technologies as applied to clinical trials.
• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
• Strong knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.