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Clinical Trial Management Associate

2 months ago

Foster City, United States INTELLECTT INC Full time

Job Title:

Sr. Clinical Trial Management Associate (Senior CTMA)

Location: Foster City, CA

Function:

Clinical Operations – Biomarker and Bioanalytical Operations

.

Position Overview:

Clinical Operations overseas worldwide Phase I-IV clinical trials across all therapeutic areas, ensuring adherence to SOPs, company policies, and regulatory guidelines. This role supports start-up, maintenance, and close-out of clinical studies, managing components of studies and vendor interactions.

Key Responsibilities

Lead/manage components of Phase I-III studies. Assist in vendor selection and manage interactions. Coordinate operational activities for biological sample collection and analysis. Manage study timelines, documentation, and communications. Act as a point of contact for stakeholders. Participate in project meetings, protocol reviews, and special projects. Develop tools and processes for project efficiency. Identify and resolve operational challenges.

Requirements

MA/MS/PharmD/PhD with 2+ years or BA/BS/RN with 4+ years’ relevant clinical experience. Experience managing external vendors. Fast learner, flexible, and adaptable. Knowledge of clinical study management, FDA, EMA, ICH guidelines, and GCP. Strong Microsoft and communication skills.

Nice To Have

Clinical operations/bioanalytical operations experience. Laboratory experience.

Unique Selling Point

Work with a diverse and cross-functional group.

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