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 components of clinical studies.

• Ensure that clinical trials adhere to protocols, standard operating procedures (SOPs), ICH-GCP, and relevant regulatory requirements.

• Serve as the main clinical point of contact for the client.

• Collaborate with the Project Manager on monthly invoicing and managing clinical budget variances.

• Create clinical documents, study plans, forms, manuals, guidelines, trackers, presentations, and training materials.

• Identify training needs for Clinical Research Associates (CRAs) and third-party vendors, and deliver training during investigator and study kick-off meetings.

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

• Develop strategies for country recruitment and retention.

• Coordinate activities related to feasibility, site start-up, enrollment, maintenance, and close-out procedures.

• Lead internal clinical team meetings and establish expectations for CRAs and Clinical Trial Assistants (CTAs).

• Address inquiries from CRAs and sites while maintaining logs of frequently asked questions (FAQs).

• Provide support for investigator meetings.

• Review or approve packages for investigational product release.

• Oversee submissions and approvals to Competent Authorities and Institutional Review Boards (IRB)/Ethics Committees.

• Develop clinical monitoring strategies and monitor study timelines and quality deliverables.

• Generate and utilize metric reports, including Clinical Trial Management System (CTMS) data, data management query trends, and outstanding monitoring reports.

• Implement and manage the electronic Trial Master File (eTMF).

• Develop and execute Corrective and Preventive Action (CAPA) plans in collaboration with the Project Manager, CRAs, and Quality Assurance (QA).

• Assist sites, staff, and CRAs with preparation for Good Clinical Practice (GCP) audits.

• Escalate performance issues related to CRAs and site compliance.

• Work with data management and CRAs to ensure data quality and timely data cleaning.

• Manage accountability and reconciliation of investigational products.

• Assume project management responsibilities in the absence of a cross-functional Project Manager.

• Support business development and marketing initiatives.

• Negotiate site budgets and investigator contracts when necessary.

• Review site visit reports to ensure monitoring aligns with the monitoring plan.

• Manage clinical vendors as required.

• Conduct clinical data reviews and generate queries as needed.

• May have responsibilities related to line 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 or demonstrated competencies for the role, with considerable clinical monitoring expertise.

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

• Exceptional communication and interpersonal skills to effectively engage with others in a team environment.

• Strong organizational abilities, keen attention to detail, and a customer service-oriented attitude.

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

• Comprehensive knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidelines.

• Familiarity with clinical management techniques and tools.

• Direct experience working in a cross-functional environment.

• Proven skills in functional management, planning, risk management, and change management.

• In-depth experience in pharmaceutical and/or device research is essential.

• Demonstrated success in independent negotiation and conflict resolution strategies.

• Candidates must possess legal authorization to work in the country of employment without requiring employer sponsorship.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance coverage.

• Retirement savings benefits.

• Life insurance policies.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.