Project Manager - Clinical Research
Core
Planning, executing, and monitoring clinical trials while managing data integrity, cleaning, analysis, and publications to support evidence-based decision-making.
Role type
Senior Clinical Research Associate / Project Manager
Builds
Clinical trials for microbiome health diagnostics and therapeutic programs
Domain
Biotechnology / Clinical Research / Microbiome
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
ICH-GCP guidelines knowledge, FDA regulations knowledge, data cleaning, query management, edit checks, outlier detection, database lock processes, database reconciliation, cross-system data matching, discrepancy resolution, audit trail maintenance, study protocol validation, budget tracking, contract processing, site qualification, site initiation, monitoring visits, close-out visits, regulatory document preparation, ethics committee submission, investigator communication, stakeholder coordination, meeting organization, action item follow-up
Preferred skills
Pharmaceutical/biotech/CRO experience, ACRP/SOCRA certification, real-world data (RWD) platform exposure, clinical dashboard exposure
Technologies
G Suite, SPSS
Responsibilities
Plan, coordinate, and manage clinical trials from site initiation to study close-out; Conduct and document site qualification, initiation, monitoring, and close-out visits; Ensure compliance with Good Clinical Practice (GCP) and regulatory requirements; Validate incoming data against study protocols; Manage database reconciliation activities; Maintain trial master files (TMF) and audit trails; Assist in processing study invoices, contracts, and budgets; Support data collection, cleaning, analysis, and publications.
Seniority
Senior, hands-on IC
