[Hiring] Clinical Data Manager @Precision for Medicine

Role Description

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.

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, study specific plans, and guidelines will be followed. This position will also oversee and/or perform database development and testing.

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s).
• 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 to ensure clinical data management deadlines are met with quality.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
• May assist in building clinical databases.
• Conduct database build UAT and maintain quality controlled database build documentation.
• Specify requirements for all edit check types and oversee development of the edit check specifications.
• Responsible for creating, revising, and maintaining data management documentation.
• Train clinical research personnel on study specific CRF, EDC, and other project-related items.
• 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 in a project-manager capacity.
• May assist with SAS programming and quality control of SAS programs.
• Identify and troubleshoot operational problems based on metrics data and audit reports.
• May assist in reviewing and providing feedback on protocols, SAP, and CSRs.
• Participate in the development and maintenance of SOPs related to data management activities.
• May attend strategy meetings, bid defense prep meetings, and potential client engagement meetings.
• Provide leadership for cross-functional and organization-wide initiatives.
• Train and ensure that all data management project team members have been sufficiently trained.
• Communicate with study sponsors, vendors, and project teams regarding data-related issues.
• May present software demonstrations/trainings and present at project meetings.
• May require some travel.
• Perform other duties as assigned.

Qualifications

• Bachelors and/or a combination of related experience.
• 8+ years’ experience for a Sr. Clinical Data Manager and 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 in utilizing various clinical database management systems.
• Broad knowledge of drug, device and/or biologic development and effective data management practices.
• Strong representational skills and ability to communicate effectively.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.

Requirements

• 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.

Company Description