Precision AQ

Data-driven drug access and launches

Senior Clinical Data Manager

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeNo salary listed

About the Job

Requirements

A bachelor's degree or a combination of related experience is required.
A Senior Clinical Data Manager requires at least 8 years of experience; a Principal Clinical Data Manager requires at least 10 years of experience.
Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook, is required.
Experience utilizing various clinical database management systems is required.
Broad knowledge of drug, device, or biologic development and effective data management practices is required.
Professional use of English, both written and oral, is required.
Ability to handle a variety of clinical research tasks is required.
Strong organizational and communication skills are 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 completion of tasks; support another Lead Data Manager as backup or team member and provide Data Management oversight of sponsor programs when applicable.
Oversee project data entry, including development of data entry guidelines, training, data entry 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 the clinical study protocol and coordinate review and feedback from stakeholders.
Assist in building clinical databases when needed.
Conduct user acceptance testing of database builds, maintain quality-controlled database build documentation, and oversee overall clinical database quality.
Specify requirements for electronic and manual edit checks and other edit check types when needed; oversee development of edit check and manual data review specifications.
Create, revise, version, and maintain data management documentation; oversee completeness 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 based on guidance from the sponsor or Lead Data Manager.
Run patient- and study-level status and metric reporting.
Perform medical coding of medical terms relative to each other 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, in a project-manager capacity to support timelines and data-related deliverables.
Assist with Statistical Analysis System programming and quality control of programs used in the Data Management department when needed.
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and 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 related process documentation for data management and database management activities.
Attend strategy meetings, bid-defense preparation meetings, bid defenses, capability presentations, and potential client engagement meetings when needed.
Review requests for proposals and proposals, and provide project estimates when needed.
Provide leadership for cross-functional and organization-wide initiatives where applicable.
Train and ensure that all data management project team members are sufficiently trained.
Communicate with study sponsors, vendors, and project teams about data, database, or other relevant project issues as needed.
Present software demonstrations or training, department or company training sessions, and project meetings when needed.
Perform other duties as assigned.

Desired Qualifications

Experience in a clinical, scientific, or healthcare discipline is preferred.
Experience with dictionary-based 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.

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 and manages 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.

Essential functions of the job include but are not limited to:

Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. 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, assesses and manage timelines. Ensure that 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 the 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, etc. Oversee development of the edit check specifications and manual data review specifications
Responsible for creating, revising, appropriate 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 the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Coordinate SAE/AE reconciliation
Liaises 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, potential client engagement meetings
May review Request for Proposals (RFP), proposals, provide project estimates
Provide leadership for cross-functional and organization-wide initiatives, where applicable
Trains and ensures that 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, present at project meetings
May require some travel
Perform other duties as assigned

Qualifications:
Minimum Required:

Bachelors and/or a combination of related experience

Other Required:

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, 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

#LI-REMOTE

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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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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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