Clinical Trials Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Overseeing and coordinating all elements of a clinical study

• Monitoring sites involved in clinical trials

• Supporting the Clinical Program Manager with comprehensive study management

• Preparing and coordinating the review of pertinent documents such as protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports

• Keeping track of study schedules

• Assisting in the formulation of the study budget

• Aiding in the creation of RFPs and participating in the selection process for CROs/vendors

• Managing relationships with CROs/vendors

• Overseeing the review of data listings and the preparation of interim and final clinical study reports

• Potentially contributing to the creation of abstracts, presentations, and manuscripts

• Ensuring the efficiency of the site budget and contract processes

• May provide training to CROs, vendors, investigators, and study coordinators on study requirements

• Assisting in identifying activities that align with project priorities within the functional area

• Under supervision, may design scientific communications for internal use

• Travel will be necessary

⛳️ Requirements

• Minimum of 6 years of experience

• Bachelor’s degree in a relevant scientific field

• Registered Nurse (2 or 3 year certificate)

• Comprehensive knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs related to the conduct of clinical trials

• Ability to generally understand, interpret, and communicate protocol requirements to others

• Capable of prioritizing multiple tasks effectively

• Strong teamwork, communication, decision-making, and organizational abilities

🏝️ Benefits

• Discretionary annual bonus

• Discretionary stock-based long-term incentives (eligibility may vary based on role)

• Paid time off

• Company-sponsored medical, dental, vision, and life insurance plans