Clinical Trial Manager – FSP

This is a fully remote position, open to applicants in Rhode Island.

📋 Description

• Oversee all clinical operational and quality aspects of assigned low- to moderate-complexity studies, ensuring compliance with ICH GCP.

• Create clinical tools, including Monitoring Plans and Monitoring Guidelines, aligned with the Data Quality Plan.

• Contribute to the development of the Master Action Plan for documents related to clinical activities.

• Ensure the timely setup, organization, content, and quality of pertinent sections of the Trial Master File.

• Participate in the design and creation of CRFs, CRF guidelines, informed consent templates, and protocol-specific documents.

• Collaborate with the project manager to prepare, organize, and present materials for client meetings, including bid defense and hand-off sessions.

• Work together with clinical and other departmental teams to achieve project deliverables.

• Maintain regular communication with the team and lead meetings to uphold timelines, resources, interactions, and quality standards.

• Implement and provide training on standardized clinical monitoring processes.

• Archive documents and study materials promptly.

• Ensure the completion of final clinical deliverables within contractual timelines by monitoring activity timelines and metrics, offering status updates, reviewing projects, implementing recovery actions, checking monitoring visit reports, and managing CRF collection and query resolution.

• Monitor or co-monitor clinical trials to evaluate performance and fulfill contractual obligations.

• Conduct Accompanied Field Visits and oversee project financials in smaller regions.

• Liaise with study sites regarding protocol, patient participation, case report forms, and study-related concerns.

• Coordinate study start-up activities and ensure timely submissions to ethics committees and regulatory bodies.

• Guarantee that essential document quality meets expectations for Regulatory Compliance Review.

• Review and address questions from ethics committees.

• Provide insights into forecasts for clinical activities.

• Manage clinical resources, delegate responsibilities, and identify additional resource needs.

⛳️ Requirements

• Bachelor's degree or equivalent along with relevant formal academic or vocational qualifications.

• A minimum of 5 years of comparable experience.

• Proven ability to manage multiple studies and competing priorities simultaneously.

• Strong understanding of Australia's study start-up processes, regulatory submissions, and investigator site contracts and budgets.

• Familiarity with clinical monitoring practices, processes, and requirements.

• Knowledge of relevant regulations, including ICH/GCP and FDA guidelines.

• Proficiency in the English language.

• Excellent oral and written communication skills.

• Competent computer skills with Outlook, Excel, Word, and similar applications.

• Financial acumen and familiarity with budgeting, forecasting, and fiscal management.

• Strong planning, organizational, interpersonal, problem-solving, judgment, and decision-making abilities.

• Capacity to work effectively in a dynamic environment with complex or ambiguous challenges.

• Experience in oncology is considered advantageous.

• Experience with study start-up processes within Australia is viewed as an asset.

🏝️ Benefits

• Comprehensive benefits package.

• Wellness programs available.

• Employee Assistance Program offering confidential support for personal and work-related matters.

• Flexible work arrangements.

• Generous leave policies.

• Option to purchase additional leave.

• Paid birthday leave.

• Company-funded parental leave.

• Paid volunteer time.

• Access to online courses through Thermo Fisher Scientific University Plus and LinkedIn Learning.

• Workshops offered.

• Mentorship programs available.