Senior Clinical Data Manager

Cytel; Colombia; Remote; COP 180,000,000 - 360,000,000; Full time

Job summary

Cytel is seeking a Senior Clinical Data Manager to work embedded with a sponsor and drive data management excellence across a global clinical program.

You will lead DM activities, oversee CROs, ensure regulatory readiness, and collaborate across functions to meet milestones with high quality.

Qualifications

• 5+ years of Clinical Data Management experience.
• Bachelor's degree in science or related field.
• Experience across development phases in at least one therapeutic area.
• Strong knowledge of FDA and ICH regulations for data capture and management.
• Proven ability to manage budgets and timelines with CROs.
• Archival and inspection readiness of TMF documents.

Responsibilities

• Lead or support data management activities and CRO oversight.
• Ensure data quality and timely delivery across databases.
• Represent data management in cross-functional governance and audits.
• Maintain SOPs, process maps, and templates for operations.
• Prepare metrics and KPIs for data management functions.
• Manage external DM budgets and forecasting.

Skills

Data management

Regulatory knowledge

Leadership

Cross-functional collaboration

Vendor management

Risk mitigation

SOPs and processes

Audit and inspections

Education

Bachelor's degree in science or related field

Tools

EDC systems

CDISC standards

SOP management tools

Job description

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.

• 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.

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.

Cytel Inc. is an Equal Employment / Aff