Senior Regional Clinical Trial Management Associate

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

📋 Description

• Assist the Regional Clinical Study Manager in the delivery of regional studies and assigned clinical study components.

• Aid Clinical Research Associates and/or Study Start-up Specialists in the execution of country-specific studies.

• Utilize knowledge of clinical trial operations to ensure regional deliverables align with overall study objectives.

• Contribute to regional vendor management and various regional study management tasks.

• Engage in internal working groups and initiatives.

• Act as a subject matter expert in a particular process and may provide mentorship to team members.

• Assist in feasibility assessments, study start-up, document generation and review, sample tracking, and participant enrollment.

• Support updates to the CTMS, preparation of ISF binders, document collection, ICF customization, and maintenance of the eTMF.

• Aid in the preparation for monitoring visits, equipment management, contract activities, regulatory submissions, TMF filing, and SUSAR submissions.

• Establish and manage SharePoint folders, distribution lists, and country/site records within eTMF and CTMS.

• Provide assistance with system access and user account management throughout the study's lifecycle.

• Facilitate local adaptation and review of study-related documentation.

• Support investigator meetings, creation and quality control of the TMF, resolution of clinical supplies issues, data cleaning, site communications, and routine site inquiries.

• Assist in maintaining public registry information and input for Clinical Study Reports.

• Aid in the identification of operational risks, quality assurance audits and inspections, process enhancements, tools, work instructions, and SOPs.

• Support vendor selection processes, regional study budgets, purchase orders, follow-up on payments, and accrual activities.

⛳️ Requirements

• A bachelor's degree in a scientific or healthcare discipline is preferred; a higher degree is advantageous.

• Candidates with relevant clinical operations experience may be considered despite lacking a degree.

• A minimum of 2 years of experience in clinical research within the biotech, pharmaceutical, or CRO industry is required.

• Knowledge of clinical operations methodologies and an understanding of the operational aspects of clinical study processes are essential.

• Proficiency in MS Office, eTMF, and CTMS is necessary.

• Occasional travel may be required.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life insurance.

• Paid Time Off.

• Wellness benefits.