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 execution of regional studies and assigned clinical study tasks.

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

• Facilitate the conduct of clinical trials, which includes feasibility assessments, study initiation, document creation and review, sample tracking, and participant recruitment.

• Assist with updates to the Clinical Trial Management System (CTMS), preparation of the Investigator Site File (ISF), collection of documents, customization of Informed Consent Forms (ICF), and maintenance of the electronic Trial Master File (eTMF).

• Interpret and apply relevant regulations and International Council for Harmonisation (ICH) guidelines.

• Organize meetings for regional and country teams, including the preparation of agendas and minutes.

• Maintain SharePoint directories, distribution lists, eTMF, CTMS, and other related study systems.

• Facilitate user access requests and manage user accounts.

• Assist with study initiation, investigator meetings, creation, review, and quality assurance of the TMF.

• Help troubleshoot regional or country clinical supply challenges and assist with data cleaning efforts.

• Prepare newsletters for study sites and handle clinical trial communications.

• Support the maintenance of public registry information and contribute to Clinical Study Report preparations.

• Aid in the identification of operational risks, audits, inspections, tools, work instructions, and Standard Operating Procedures (SOPs).

• Assist with vendor onboarding, development of regional study budgets, management of purchase orders, follow-up on payments, and accrual activities.

⛳️ Requirements

• A minimum of 1 year of experience in clinical research within the biotech, pharmaceutical, or Contract Research Organization (CRO) sectors.

• Familiarity with clinical operations methodologies and an understanding of the operational components of clinical study processes.

• Proficiency in MS Office, eTMF, and CTMS.

• A Bachelor’s Degree is preferred, ideally in a scientific or healthcare-related field.

• Occasional travel may be necessary.

• Exceptions may be considered for candidates with pertinent clinical operations experience.

🏝️ Benefits

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

• Eligibility for an incentive compensation plan for commercial roles.

• Availability of discretionary equity awards.

• Participation in the Voluntary Employee Stock Purchase Plan.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• 401(k) retirement plan.

• Flexible Spending Account (FSA)/Health Savings Account (HSA).

• Life insurance coverage.

• Paid time off.

• Wellness programs.