Clinical Trial Manager

This is a fully remote position, open to applicants in Arizona, +4 more states.

📋 Description

• Accountable for overseeing site management, clinical monitoring, and central monitoring deliverables with an emphasis on patient safety, compliance with protocols/GCP/regulatory standards, and data integrity.

• Manages site interactions from activation through to closeout.

• Responsibilities may include patient recruitment, investigator payments, and other related tasks.

• May involve identifying critical data and processes, assessing protocol execution risks, and implementing risk mitigations related to the completion of the Risk Assessment and Categorization Tool (RACT).

• Reviews the study's scope of work, budget, and protocol content, ensuring the clinical project team (CRAs/CeMs) understands contractual obligations and parameters.

• Utilizes previous clinical experience, operational data, metrics, and reports to identify risks affecting clinical trial management deliverables.

• Escalates any risks to the project manager regarding clinical trial management deliverables (timeline, quality, and budget) and any activities and requests outside of the contracted scope.

• Applies strategic thinking and problem-solving skills to suggest and implement risk mitigations.

• Participates in and presents at key meetings, such as the Kick Off Meeting.

• Acts as a point of escalation for communications with investigator site staff and may need to interact with principal investigators or other site staff via phone or in person.

• Collaborates with other functional leaders, including Study Start Up, Patient Recruitment, and Data Management, to coordinate handoffs and meet study milestones such as site activation targets, enrollment goals, and database lock timelines.

• Reviews and offers input on other functional plans (e.g., Data Management Plan, Communication Plan) in relation to clinical trial management activities.

• Responsible for the development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.

• Ensures that CTMS, dashboards, and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as necessary.

• Ensures that access and audit trail reviews are conducted as required.

• Coordinates initial and ongoing training for the study team regarding protocol specifics, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans, and study timelines.

• Oversees resource allocation for CRAs and Central Monitors, site assignments, and the conduct of study team members, identifying risks to delivery or quality.

• Guarantees the quality of clinical monitoring, central monitoring, and site management deliverables within a project while maintaining proper visibility of its progress using approved systems or tracking tools.

• Reviews project oversight dashboards and other clinical trial systems (e.g., Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities, study team conduct, and ensure data is updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.

• Understands the required monitoring strategy for the study and, when needed, participates in developing the study risk assessment plan.

• Takes responsibility for ensuring their assigned clinical team members comprehend, comply with, and deliver according to the specified monitoring strategy, CMP/SMP, and risk plans.

• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports, and relevant correspondence) to ensure they accurately reflect site management activities and conduct, and appropriately communicate any risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity.

• Documents requested revisions and approvals in CTMS.

• Ensures deliverables are provided according to company and/or sponsor specifications, including meeting delivery deadlines.

• Engages with clients and other functional departments concerning clinical monitoring, central monitoring, and site management activities and deliverables.

• Provides status updates on clinical deliverables and risks to clients, project management, and leadership in accordance with departmental or study agreements.

• Offers solutions for challenges in protocol execution and site management.

• Demonstrates an understanding of the roles of other functions in ensuring compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations.

• Supports Inspection Readiness for the scope of clinical trial management.

• Oversees CRAs and Central Monitors assigned to the study and routinely evaluates study-specific process and training compliance, CMP compliance, and identifies emerging risks.

• Develops and supports the execution of corrective action plans at both the site and study levels.

• Assists in completing activities to meet data cut and lock deadlines.

• Provides feedback to line managers on staff performance, highlighting both strengths and areas for improvement.

• May be tasked with larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects.

• May also coach and mentor CTMs on functional clinical delivery, evaluating project risks, and implementing actions.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or equivalent combination of education, training, and experience.

• Proven ability to lead and align teams to achieve project milestones.

• Demonstrated experience working in an international environment.

• Established expertise in site management and monitoring (clinical or central).

• Preferred experience in risk-based monitoring.

• Demonstrates an understanding of clinical trial management financial principles and budget management.

• Knowledgeable in Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.

• Must exhibit proficient computer skills.

• Strong conflict resolution abilities.

• Proven capacity to apply problem-solving techniques to address complex issues and utilize a risk management approach to identify and mitigate potential threats to the successful execution of a clinical research project.

• Exhibits critical thinking to ascertain the cause and appropriate solutions when identifying issues.

• Moderate travel may be required, approximately 20%.

🏝️ Benefits

• Company car or car allowance.

• Health benefits including Medical, Dental, and Vision coverage.

• Company match for 401k contributions.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on individual and company performance.

• Flexible paid time off (PTO) and sick leave.