Senior Clinical Trial Manager- Imaging Study - BridgeBio

What You'll Do

The Senior Clinical Trial Manager is responsible for the execution and management of assigned clinical studies while ensuring Good Clinical Practices (GCP) Compliance, high study quality, and timely completion. This position is responsible for assisting in meeting functional, organizational, and corporate goals for acoramidis (AG10) by providing successful management of clinical study teams and clinical trials

Responsibilities

• Leads the Clinical Study Team for assigned projects; may lead one or more clinical studies, from concept to protocol, and achieve corporate objectives and key milestones such as First Patient In, Interim Analysis, Database lock, etc.

• Manage external vendors and contract research organizations, may manage internal resources such as Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)

• Prepare/Review/Approve study documents such as the Monitoring Manual, Study Operational Manual, Source Data Verifications Plan, and Laboratory Manual

• Coordinate and design study materials such as CRFs, patient diaries, study participation cards, and source documents.

• Manage operational activities at the study level and monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to GCP, Standard Operating Procedures (SOPs), and study

  protocols

• Negotiate and mange vendor work agreements an site contracts

Where You'll Work

This is a U.S.based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

Historically the "Experience, Education, & Skills Requirement" section

(5-7 bullets max)

• Bachelor’s degree in a scientific discipline or equivalent is required, and an advanced degree

  is preferred

• Requires at least eight years of biopharma industry experience (relevant clinical trials experience, in the biotechnology, pharmaceutical, CRO, medical device industry) with at least two years managing clinical trials

• Must have vendor management experience in clinical operations/development

• Strong verbal and written communication skills, can communicate strategic direction and relevant context so that employees at all levels understand their role in achieving success

• Ability to build and maintain strong working relationships within the department and cross- functionally to meet a project or corporate goal

• Experience with Microsoft Office Suite required (Word, Excel, Project, Outlook)

• Must be able and willing to travel periodically