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VARITE INC · 3 weeks ago

Clinical Trials Management Associate - III

Santa Monica, CA

Full-time

Hybrid

Mid, Senior Level

$62/hr - $67.10/hr

4+ years exp

VARITE INC is a company focused on clinical trials and they are seeking a Senior Clinical Trials Management Associate. The role involves overseeing various aspects of clinical trial conduct, including study start-up, document management, and vendor oversight, while ensuring compliance with FDA regulations and ICH guidelines.

Information Technology & Services

Growth Opportunities

Responsibilities

Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the study manager (e.g., Clinical protocols, Informed Consent Forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters)

Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met. Provides corrective instruction, as necessary, when performance expectations are not being met

Attends internal team and other meetings as required

Provides training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences

Creates and reviews site feasibility assessments required for study participation

Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations

Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to Senior Manager

Prepares metrics and updates to key deliverables for management

Assists in the resolution of clinical trial queries and data review for interim analysis, primary analysis and final database locks

Prepares site newsletters and other correspondence related to clinical trial conduct (e.g., best practices and lessons learned, frequently asked questions) in collaboration with the study team

Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol

May lead less complex studies and/or manage components of more complex studies as a member of the study team

May participate in department initiatives or special projects, such as developing new tools or processes

Ability to coach less experienced colleagues in solving problems

Understands how decisions have an impact to the broader study goals

Other duties as assigned

Qualification

Clinical trial managementFDA regulations/ICH guidelinesOncology experienceHematology experienceCell therapy experienceAnalytical skillsInterpersonal skillsOrganizational skillsProblem solvingCommunication skillsAttention to detail