Precision for Medicine

Healthcare

SeniorClinicalDataManager

$750–1200k ~AI est. Mexico City, Mexico
The Brief

“Senior Clinical Data Manager at Precision for Medicine. Skills: Clinical data management, Database management, Data quality, Regulatory compliance. Manage clinical trial data management process. Oversee database development and testing”

What You'll Achieve.

Ensure data management deadlines are met with quality

Industry & Context.

Healthcare
Problems you'll solve

Troubleshoot operational problems; Identify operational issues; Identify study obstacles

Eligibility Requirements

Occasional travel

What They're Looking For.

Must Have

Bachelors and/or related experience, English proficient (Professional level), 8+ years’ experience, Proficiency in Microsoft Office, Excellent organizational skills, Excellent communication skills, Professional use of English (written and oral), Experience in clinical database management systems, Broad knowledge of drug/device/biologic development, Effective data management practices, Representational skills, Leadership skills, Interpersonal skills

Nice to Have

PhD preferred, Experience in clinical/scientific/healthcare discipline, Dictionary medical coding experience, Understanding of CDISC standards, Oncology therapeutic experience, Orphan Drug therapeutic experience

What You'll Do.

Manage clinical trial data management process

Oversee database development and testing

Serve as Primary Data Management contact

Ensure task continuity and responsiveness

Oversee project data entry process

Develop data entry guidelines

Assess and manage timelines

Ensure data management deadlines are met

Assess resource needs for projects

Develop CRF specifications

Coordinate CRF specification review

Assist in building clinical databases

Conduct database build UAT

Maintain database build documentation

Oversee clinical database quality

Specify edit check requirements

Oversee edit check development

Create data management documentation

Revise data management documentation

Maintain data management documentation

Oversee documentation completeness for TMF

Train personnel on CRF and EDC

Review and query clinical trial data

Perform line listing data review

Run patient and study status reporting

Perform medical coding

Coordinate SAE/AE reconciliation

Liaise with third-party vendors

Support vendor timelines and deliverables

Troubleshoot operational problems

Identify study obstacles

Provide feedback on protocols

Provide feedback on SAPs

Provide feedback on CSRs

Participate in SOP development

Participate in SOP maintenance

Attend strategy meetings

Attend bid defense prep meetings

Attend capability presentations

Attend client engagement meetings

Provide project estimates

Provide leadership for initiatives

Train data management team members

Communicate with study sponsors

Communicate with vendors

Communicate with project teams

Present software demonstrations

Present department training sessions

Present company training sessions

Present at project meetings

Perform other duties as assigned

How You'll Work.

Team & Collaboration

Cross-functional teams; Project team members; Study sponsors; Vendors; Project teams

Communication Scope

Verbal communication; Written communication; Representational skills

Process & Methodology

Timeline management, Resource assessment, Project estimates

Free ATS check

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