Hire Talented Clinical Research Associate

TMF Lead (eTMF Owner)

Results-driven Clinical Research and TMF Management professional with 12+ years of experience across clinical operations, site management, and regulatory documentation. Proven expertise in eTMF management, audit readiness, and compliance with ICH-GCP and global regulatory standards. Skilled in WingSpan, Veeva Vault, CTMS, and NextDoc platforms for document lifecycle management. Recognized for streamlining TMF operations, leading cross-functional teams, and maintaining inspection-ready documentation across global Phase II–IV studies.

Clinical Research Associate

Dedicated Clinical Research Associate (CRA) with 7+ years of experience managing Phase II–IV clinical trials and bioequivalence studies in accordance with ICH-GCP and global regulatory standards. Skilled in site monitoring, trial documentation, source data verification, IP accountability, and TMF management. Strong track record of inspection readiness, stakeholder communication, and timely, high-quality data delivery across diverse therapeutic areas including oncology, rheumatology, psychiatry, and metabolic disorders.

TMF Lead

Results-driven Clinical Research and TMF Management professional with 10+ years of experience in managing the complete Trial Master File (TMF) lifecycle across global pharmaceutical and CRO environments. Proven expertise in TMF inspection readiness, quality oversight, and regulatory compliance (ICH-GCP, CFR, EMA, MHRA). Adept at stakeholder coordination, documentation excellence, and audit preparation, ensuring TMF accuracy and integrity from study startup to closeout. Recognized for process improvements, cross-functional training, and maintaining audit-ready environments across multiple therapeutic domains.

Senior TMF Document Specialist

Experienced Clinical Research and TMF Specialist with 9+ years of experience in managing Trial Master File (TMF) operations, clinical documentation, and regulatory compliance in global CRO environments. Proficient in eTMF systems (Veeva Vault, WINGSPAN, ELVIS) and skilled in document quality review, audit readiness, TMF reconciliation, and records management. Adept at ensuring ICH-GCP compliance, maintaining inspection-ready documentation, and driving process optimization. Recognized for team leadership, cross-functional collaboration, and mentoring junior TMF staff.

Clinical Research and Study Delivery Specialist

Dynamic Clinical Research and Study Delivery Specialist with 9+ years of experience in global pharmaceutical and CRO environments, specializing in project management, TMF operations, and study documentation. Expertise spans Phase II–III clinical trials, inspection readiness, and vendor oversight. Skilled in study startup, conduct, and closeout, ensuring compliance with ICH-GCP and regulatory standards. Strong proficiency in eTMF systems (Veeva Vault, Wingspan, ELVIS) and study delivery tools including Study Maestro, FIORI, and IQVIA Clinical Trial Payments. Recognized for driving operational excellence, process optimization, and cross-functional team leadership.