Senior Clinical Data Manager

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

📋 Description

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

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

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

• Provide backup support and/or collaborate with other Lead Data Managers; may supervise sponsor programs.

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

• Conduct quality control of data entry when necessary.

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

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

• Assist in building clinical databases.

• Conduct user acceptance testing (UAT) for database builds and maintain the documentation for controlled database builds.

• Ensure the quality of clinical databases.

• Specify and manage electronic/manual edit checks and manual data review specifications.

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

• Train clinical research personnel and data management project team members on CRFs, EDC, and project-related matters.

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

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

• Conduct medical coding and coordinate SAE/AE reconciliation.

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

• Assist with SAS programming and perform quality control of SAS programs when necessary.

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

• Review and provide input on protocols, SAPs, and CSRs when necessary.

• Engage in the development and maintenance of SOPs and process documentation.

• Support strategy meetings, bid defenses, capability presentations, and potential client engagement meetings.

• Review RFPs and proposals, and provide project estimates when required.

• Lead cross-functional and organization-wide initiatives.

• Communicate with study sponsors, vendors, and project teams about data, databases, and project-related issues.

• Deliver software demonstrations, trainings, and participate in project meetings.

• Execute other assigned responsibilities.

⛳️ 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.

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

• Capable of managing a variety of clinical research tasks.

• Strong organizational and communication skills.

• Professional proficiency in English, both written and spoken.

• Experience with various clinical database management systems.

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

• Strong representational abilities, with effective oral and written communication skills.

• Excellent leadership and interpersonal skills.

• Willingness to travel occasionally.

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

• Preferred: Knowledge of 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 requiring employer sponsorship.

🏝️ Benefits

• May involve some travel.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.

• No employer sponsorship required; candidates must be legally authorized to work in the country of employment.