Senior Clinical Data Manager

This is a fully remote position, open to applicants in Mexico, +5 more countries.

📋 Description

• Act as the main Data Management contact and Lead DM for designated clinical projects/programs.

• Supervise data entry procedures, guidelines, training, quality assurance, and resource allocation.

• Manage timelines, resource requirements, and deadlines for clinical data management.

• Develop CRF specifications based on clinical study protocols and coordinate stakeholder feedback.

• Assist in constructing clinical databases and conduct user acceptance testing (UAT) for database builds.

• Oversee the quality of databases, edit check specifications, manual data review guidelines, and documentation for builds.

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

• Train clinical research personnel and members of the data management project team on CRFs, EDC, and project specifications.

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

• Conduct line-listing data reviews alongside patient/study status and metric reporting.

• Execute medical coding and manage SAE/AE reconciliation.

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

• Troubleshoot operational challenges using metrics, audit reports, and input from stakeholders.

• Engage in SOP development, protocol/SAP/CSR reviews, strategy meetings, proposals, and client interactions as necessary.

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

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

• Occasional travel and other assigned responsibilities may be required.

⛳️ Requirements

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

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

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

• Capable of managing a diverse range of clinical research tasks.

• Exceptional organizational and communication abilities.

• Professional command of the English language, both written and spoken.

• Experience with various clinical database management systems.

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

• Strong representational abilities and effective communication skills, both orally and in writing.

• Proven leadership and interpersonal skills.

• Willingness to undertake occasional travel.

• Candidates must possess legal authorization to work in the country of employment without the need for employer sponsorship.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements and a supportive work environment.