Senior Clinical Data Manager

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

📋 Description

• Act as the main Data Management point of contact for designated clinical projects/programs, ensuring consistent communication, responsiveness, backup support, and timely task fulfillment.

• Supervise data entry processes for projects, including guidelines, training, quality assurance, and resource allocation.

• Contribute to and manage project timelines, deadlines, and resource requirements.

• Create Case Report Form (CRF) specifications based on clinical study protocols and coordinate review with stakeholders.

• Aid in the construction of clinical databases and perform user acceptance testing for database builds.

• Maintain documentation for database builds under quality control and oversee the overall quality of clinical databases.

• Define and supervise edit-checks and manual data review protocols.

• Develop, update, and maintain data management documentation and ensure the completeness of the Trial Master File.

• Educate clinical research staff and data management project team members on CRFs, Electronic Data Capture (EDC), and project-specific matters.

• Analyze and query clinical trial data according to the Data Management Plan.

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

• Execute medical coding and manage Serious Adverse Event (SAE) and Adverse Event (AE) reconciliation.

• Collaborate with external data and EDC vendors concerning timelines and data-related deliverables.

• Assist in SAS programming and ensure quality control of SAS programs.

• Identify and resolve operational issues utilizing metrics, audit reports, and stakeholder feedback.

• Review and provide input on protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs) as necessary.

• Engage in the development and maintenance of Standard Operating Procedures (SOPs) and process documentation.

• Support strategy meetings, bid defenses, capability presentations, client engagement meetings, RFP reviews, proposals, and project estimates as required.

• Provide leadership in cross-functional and organization-wide initiatives.

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

• Deliver software demonstrations, training sessions, and project meetings.

• 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.

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

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

• Exceptional organizational and communication abilities.

• Professional proficiency in 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 skills and effective oral and written communication capabilities.

• Demonstrated leadership and interpersonal skills.

• Willingness to undertake occasional travel.

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

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

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

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

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

🏝️ Benefits

• May involve some travel.

• Equal Opportunity Employer.

• Reasonable accommodations available during the application process.

• AI-generated insights may be utilized throughout the application process, with an option to opt-out.