Clinical Trial Manager/Senior Clinical Trial Manager

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

📋 Description

• Act as the clinical trial lead responsible for the planning, execution, and oversight of the operational aspects of clinical studies.

• Ensure that studies adhere to protocols, SOPs, ICH-GCP, and relevant regulatory standards.

• Serve as the primary clinical contact for clients.

• Work closely with the Project Manager on monthly invoicing and management of clinical budget variances.

• Create clinical documentation, study forms, manuals, trackers, training materials, and guidelines for CRF completion.

• Identify and establish training requirements for CRAs and third-party vendors; present findings at Investigator and Study Kick-off meetings.

• Generate lists of potential sites and facilitate site feasibility assessments.

• Recognize enrollment risks and develop recruitment and retention strategies specific to each country.

• Oversee feasibility assessments, site initiation, enrollment, maintenance, and close-out processes.

• Lead internal clinical team meetings, setting clear expectations for CRAs and CTAs.

• Address queries from CRAs and sites while maintaining logs of frequently asked questions.

• Support investigator meetings and review/approve investigational product release packages.

• Manage submissions and approvals to Competent Authorities and IRB/Ethics Committees.

• Develop strategies for clinical monitoring and track timelines and quality deliverables for studies.

• Generate and analyze metrics from CTMS, including DM query trends and outstanding monitoring reports.

• Implement and oversee the management of the electronic Trial Master File (eTMF).

• Collaborate on the development, implementation, and closure of Corrective and Preventive Actions (CAPA).

• Assist sites, staff, and CRAs in preparing for GCP audits.

• Coordinate resource allocation issues, escalate performance and compliance concerns, and ensure data quality support.

• Manage accountability and reconciliation of investigational products.

• Take on project management duties when no cross-functional project manager is assigned.

• Support business development and marketing initiatives.

• Negotiate site budgets and investigator contracts as necessary.

• Review site visit reports to ensure adherence to the monitoring plan.

• Manage clinical vendors as required.

• Conduct clinical data reviews and generate queries as needed.

• May have responsibilities related to line management.

• Perform additional tasks as assigned by management.

⛳️ Requirements

• Bachelor's degree or an equivalent combination of education and experience in a science or health-related field.

• At least 7 years of clinical research experience, demonstrating competencies for the role, with significant clinical monitoring expertise.

• Proficiency in Microsoft Office products (Outlook, Word, Excel, PowerPoint).

• Exceptional communication and interpersonal skills to effectively collaborate with team members.

• Strong organizational skills, keen attention to detail, and a customer-focused approach.

• Willingness to travel both domestically and internationally, including overnight stays.

• In-depth knowledge of ICH-GCP, relevant SOPs, and regulatory guidelines.

• Familiarity with clinical management techniques and tools.

• Direct experience in a cross-functional work environment.

• Proven ability in functional management and delegation.

• Proven expertise in planning, risk management, and change management.

• Extensive experience in pharmaceutical and/or device research.

• Demonstrated success in independent negotiation and conflict resolution strategies.

• Advanced degree is preferred.

• Experience with Radiopharmaceuticals and/or CAR-T studies is preferred.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance coverage.

• Retirement savings benefits.

• Life insurance policy.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.