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Precision AQ

Data-driven drug access and launches

Senior Clinical Data Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeRemote in MexicoNo salary listed

About the Job

Requirements

  • A bachelor's degree or a combination of related experience is required.
  • At least 8 years of experience is required for a Senior Clinical Data Manager; at least 10 years is required for a Principal Clinical Data Manager.
  • Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook, is required.
  • Ability to handle a variety of clinical research tasks is required.
  • Professional use of English, both written and oral, is required.
  • Experience using various clinical database management systems is required.
  • Broad knowledge of drug, device, or biologic development and effective data management practices is required.
  • Strong representational skills and the ability to communicate effectively orally and in writing are required.
  • Strong leadership and interpersonal skills are required.
  • Ability to undertake occasional travel is required.

Responsibilities

  • Serve as the primary Data Management contact and Lead Data Manager for assigned clinical projects or programs, ensuring backup, continuity, responsiveness, and timely task completion; support another Lead Data Manager as a backup or team member, including oversight of sponsor programs when applicable.
  • Oversee project data entry, including developing data entry guidelines, training, data quality, and resourcing.
  • Perform quality control of data entry when needed.
  • Provide input on and manage timelines, ensure clinical data management deadlines are met with quality, and assess project resource needs as needed.
  • Develop case report form specifications from clinical study protocols and coordinate stakeholder review and feedback.
  • Assist in building clinical databases when needed.
  • Conduct database build user acceptance testing, maintain quality-controlled database build documentation, and oversee overall clinical database quality.
  • Specify requirements for electronic and manual edit checks and data review; oversee development of edit check and manual data review specifications when needed.
  • Create, revise, version, and maintain data management documentation, and oversee completion of data management documentation for the Trial Master File.
  • Train clinical research personnel on study-specific case report forms, electronic data capture, and other project-related items as needed.
  • Review and query clinical trial data according to the Data Management Plan.
  • Perform line-listing data review according to guidance from the sponsor or Lead Data Manager.
  • Run patient- and study-level status and metric reports.
  • Perform medical coding of related medical terms to ensure medical logic and consistency.
  • Coordinate serious adverse event and adverse event reconciliation.
  • Liaise with third-party vendors, including external data and electronic data capture vendors, to support timelines and data-related deliverables in a project-management capacity.
  • Assist with SAS programming and quality control of SAS programs used by the Data Management department when needed.
  • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies using metrics data, audit reports, and input from project team members and other stakeholders.
  • Review and provide feedback on protocols, Statistical Analysis Plans, and Clinical Study Reports when required by the project.
  • Participate in developing and maintaining Standard Operating Procedures and process documentation related to data management and database management activities.
  • Attend strategy meetings, bid-defense preparation meetings, bid defenses, capability presentations, and potential client engagement meetings as needed.
  • Review Requests for Proposals and proposals and provide project estimates as needed.
  • Provide leadership for cross-functional and organization-wide initiatives where applicable.
  • Train data management project team members and ensure they have been sufficiently trained.
  • Communicate with study sponsors, vendors, and project teams about data, database, and other relevant project issues as needed.
  • Present software demonstrations and training, department or company training sessions, and project meetings as needed.
  • Travel as required.
  • Perform other duties as assigned.

Desired Qualifications

  • Experience in a clinical, scientific, or healthcare discipline is preferred.
  • Experience with dictionary medical coding, including MedDRA and WHODrug, is preferred.
  • Understanding of CDISC standards, including CDASH, SDTM, and ADaM, is preferred.
  • Oncology or orphan drug therapeutic experience is preferred.

About the Company

Precision AQ

Data-driven drug access and launches

Precision AQ helps pharmaceutical companies get FDA-approved medicines to patients by using data, evidence, and market insights to shape access and launches. Its services combine medical science, commercial strategy, and technology development to create new pathways for drug availability and timely delivery. The company partners with drug makers to plan launches and expansion, using analytical and creative approaches to make medicines reachable and effective in real-world settings. Unlike firms that focus only on science or marketing, Precision AQ blends data-driven insights with strategic execution across development and commercialization to accelerate patient access. The goal is to raise standards in healthcare accessibility and impact by getting the right medicines to the right patients faster.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
New York City, New York
Founded
Not listed

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