Senior Clinical Data Manager

This is a fully remote position, open to applicants in Mexico, +2 more countries.

📋 Description

• Oversee every facet of clinical trial data management from the initiation of the study to post-database lock for designated projects.

• Act as the primary Data Management contact and Lead Data Manager for assigned clinical projects and programs.

• Supervise data entry processes, which encompass guidelines, training, quality assurance, resource allocation, and quality control.

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

• Create CRF specifications from clinical study protocols and facilitate stakeholder reviews.

• Assist in the construction of clinical databases and carry out User Acceptance Testing (UAT) for database builds.

• Ensure the maintenance of a quality-controlled database build and data management documentation, including the completeness of the Trial Master File.

• Define and oversee edit checks and specifications for manual data reviews.

• Provide training for clinical research personnel and members of the data management project team.

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

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

• Carry out medical coding and manage SAE/AE reconciliation.

• Coordinate with third-party data and EDC vendors concerning timelines and deliverables.

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

• Engage in the development and maintenance of SOP/process documentation.

• Communicate with study sponsors, vendors, and project teams about data and database concerns.

• Provide leadership for cross-functional and organization-wide projects.

• Participate in meetings, presentations, proposals, project estimates, software demonstrations, and training sessions.

• May assist with SAS programming and quality control of SAS programs.

• Some travel may be necessary.

• Perform additional duties as assigned.

⛳️ Requirements

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

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

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

• Capability to manage a range of clinical research tasks.

• Exceptional organizational and communication skills.

• Professional proficiency in the English language, both written and oral.

• Experience with various clinical database management systems.

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

• Strong representational, leadership, and interpersonal capabilities.

• Willingness to undertake occasional travel.

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

• Preferred: expertise in medical coding dictionaries (MedDRA and WHODrug).

• Preferred: familiarity with CDISC standards (CDASH, SDTM, ADaM, etc.).

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

• Candidates must be legally authorized to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.

• Remote work options available.

• Some travel may be necessary.