Clinical Data Manager

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

📋 Description

• Oversee all elements of the clinical trial data management process from the initiation of the study until post-database lock for assigned projects.

• Adhere to SOPs/WIs, regulatory requirements, study-specific strategies, and guidelines.

• Act as the primary Data Management liaison and Lead DM for designated clinical initiatives/programs.

• Supervise project data entry, including establishing guidelines, training, quality assurance, and resource allocation.

• Evaluate timelines and resource requirements, ensuring that data management deadlines are achieved with a focus on quality.

• Develop Case Report Form (CRF) specifications based on clinical study protocols and coordinate stakeholder reviews.

• Assist in constructing clinical databases and execute User Acceptance Testing (UAT) for database builds.

• Maintain documentation for quality-controlled database builds and supervise the integrity of clinical databases.

• Define and manage requirements for edit checks and manual data reviews.

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

• Train clinical research staff and data management project team members.

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

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

• Execute medical coding and coordinate the reconciliation of Serious Adverse Events (SAE) and Adverse Events (AE).

• Collaborate with third-party data and Electronic Data Capture (EDC) vendors regarding timelines and data-related deliverables.

• Resolve operational issues utilizing metrics, audit reports, and input from stakeholders.

• Engage in documentation of SOPs/processes, reviews of protocols/SAP/CSR, strategy meetings, proposals, estimates, and cross-functional initiatives.

• Communicate with study sponsors, vendors, and project teams concerning data and database challenges.

• Deliver software demonstrations, training sessions, and project meeting presentations.

• Fulfill other assigned tasks and undertake occasional travel as required.

⛳️ Requirements

• Bachelor's degree 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 applications: Word, Excel, PowerPoint, and Outlook.

• Capability to manage a range of clinical research responsibilities.

• Exceptional organizational and communication abilities.

• Professional proficiency in English, 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 methodologies.

• Strong representation, leadership, and interpersonal capabilities.

• Willingness to undertake occasional travel.

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

• Preferred: experience with medical coding dictionaries such as MedDRA and WHODrug.

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

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

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Professional development opportunities and continuing education.

• Flexible work schedule and remote work options.

• Collaborative and innovative work environment.