Remote Sr. Clinical Data Manager - LATAM (CRO) — Columbus

We're expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we're looking for an experienced Clinical Data Manager to help build the foundation of our growing LATAM Data Management team, ensuring the delivery of high-quality clinical data that drives successful clinical trials and accelerates innovative therapies to patients.

Position Summary:
The Senior Clinical Data Manager/Principal Clinical Data Manager is responsible for managing all aspects of the clinical trial data management process from study start-up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs), regulatory directives, and study-specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential Functions:

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring back-up, continuity, responsiveness, and timely task completion. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality, and resourcing.
• May perform quality control of data entry.
• Provide input, assess, and manage timelines. Ensure clinical data management deadlines are met with quality. Assess resource needs for assigned projects as needed.
• Develop CRF specifications from the clinical study protocol and coordinate review/feedback from all stakeholders.
• May assist in building clinical databases.
• Conduct database build UAT and maintain quality-controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types (e.g., electronic, manual data review, edit checks). Oversee development of edit check specifications and manual data review specifications.
• Responsible for creating, revising, versioning, and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study-specific CRF, EDC, and other project-related items as needed.
• Review and query clinical trial data according to the Data Management Plan.
• Perform line listing data review based on guidance provided by the sponsor and/or Lead DM.
• Run patient and study-level status and metric reporting.
• Perform medical coding of medical terms to ensure medical logic and consistency.
• Coordinate SAE/AE reconciliation.
• Liaise with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables.
• May assist with SAS programming and quality control of SAS programs used in the Data Management department.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs), if required by the project.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities.
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, and potential client engagement meetings.
• May review Request for Proposals (RFPs) and proposals, and provide project estimates.
• Provide leadership for cross-functional and organization-wide initiatives, where applicable.
• Train and ensure all data management project team members have been sufficiently trained.
• Communicate with study sponsors, vendors, and project teams as needed regarding data, database, or other relevant project issues.
• May present software demonstrations/trainings, department/company training sessions, and present at project meetings.
• May require some travel.
• Perform other duties as assigned.

Qualifications:
Minimum Required:

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

Other Required:

• 8+ years' experience for a Sr. Clinical Data Manager; 10+ years for a Principal Clinical Data Manager.
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Able to handle a variety of clinical research tasks.
• Excellent organizational and communication skills.
• Professional use of the English language, both written and oral.
• Experience utilizing various clinical database management systems.
• Broad knowledge of drug, device, and/or biologic development and effective data management practices.
• Strong representational skills; ability to communicate effectively orally and in writing.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.

Preferred:

• Experience in a clinical, scientific, or healthcare discipline.
• Dictionary medical coding (MedDRA and WHODrug).
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).
• Oncology and/or Orphan Drug therapeutic experience.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.

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