Clinical Data Manager

This is a fully remote position, open to applicants in Argentina, +5 more states.

📋 Description

• Act as the main Data Management point of contact for designated clinical projects/programs, ensuring seamless operations, responsiveness, backup support, and timely completion of tasks.

• Supervise data entry workflows, which encompass data entry protocols, training, quality assurance, and resource allocation.

• Conduct quality control of data entry as necessary.

• Evaluate and manage project timelines, deadlines, and resource requirements.

• Generate CRF specifications based on clinical study protocols and coordinate the review process with stakeholders.

• Assist in the development of clinical databases.

• Execute user acceptance testing (UAT) for database builds and maintain documentation that adheres to quality control standards.

• Ensure the quality of clinical databases.

• Define and manage requirements for edit checks and manual data review processes.

• Create, modify, version, and maintain data management documentation while ensuring the completeness of the Trial Master File.

• Provide training to clinical research staff on study-specific CRFs, electronic data capture (EDC), and project-related materials.

• Review and query clinical trial data in accordance with the Data Management Plan.

• Conduct line-listing data reviews and report patient/study-level status and metrics.

• Perform medical coding to maintain medical logic and consistency.

• Coordinate reconciliation of serious adverse events (SAE) and adverse events (AE).

• Communicate with third-party data and EDC vendors regarding timelines and data deliverables.

• Assist with SAS programming and the quality control of SAS programs as necessary.

• Identify and resolve operational issues using metrics, audit reports, and feedback from stakeholders.

• Review and provide input on protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs) as required.

• Engage in the development and maintenance of standard operating procedures (SOPs) and process documentation.

• Participate in strategy meetings, bid defense preparations, capability presentations, and client engagement discussions as necessary.

• Review requests for proposals (RFPs), proposals, and provide project estimates as required.

• Lead cross-functional and organization-wide initiatives.

• Train and ensure comprehensive training of data management project team members.

• Communicate with sponsors, vendors, and project teams regarding data, database, and project-related issues.

• Deliver software demonstrations, training sessions, and lead project meetings as required.

• Travel occasionally as needed.

• Execute additional responsibilities as assigned.

⛳️ Requirements

• Bachelor's degree and/or a combination of relevant experience.

• Minimum of 8 years’ experience for a Senior Clinical Data Manager; 10 years for a Principal Clinical Data Manager.

• Proficiency in Microsoft Office Suite: Word, Excel, PowerPoint, and Outlook.

• Capability to manage a diverse range of clinical research tasks.

• Exceptional organizational and communication abilities.

• Professional proficiency in English, both written and spoken.

• Experience with various clinical database management systems.

• Extensive knowledge of drug, device, and/or biologic development and effective data management practices.

• Strong representational skills and the ability to communicate effectively, both orally and in writing.

• Strong leadership qualities and interpersonal skills.

• Willingness to undertake occasional travel.

• Preferred: experience in a clinical, scientific, or healthcare field.

• Preferred: experience with medical coding using MedDRA and WHODrug.

• Preferred: familiarity with CDISC standards, including CDASH, SDTM, and ADaM.

• Preferred: experience in oncology and/or orphan drug therapeutic areas.

🏝️ Benefits

• Comprehensive health insurance.

• Retirement savings plan with employer contributions.

• Opportunities for professional development and continuing education.

• Flexible work arrangements.

• Generous paid time off and holiday schedule.