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, overseeing the planning, execution, and operational management of clinical studies.

• Serve as the main clinical liaison with the client.

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

• Create clinical study documents, plans, forms, manuals, trackers, slides, and training resources.

• Assess training requirements for CRAs and third-party vendors, conducting training at investigator and study kick-off meetings.

• Generate prospective site lists and facilitate site feasibility assessments.

• Identify enrollment challenges and formulate country-specific recruitment and retention strategies.

• Build communication and collaborative relationships with investigators and study teams throughout the phases of feasibility, start-up, enrollment, maintenance, and closeout.

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

• Address inquiries from CRAs and sites while maintaining an FAQ log.

• Support the planning and execution of investigator meetings.

• Review or approve packages for investigational product releases.

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

• Develop clinical monitoring strategies to ensure timely and quality compliance.

• Produce and utilize metrics from CTMS, data management query trends, and monitoring reports.

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

• Collaborate with PM, CRAs, and QA on CAPA plans, ensuring prompt resolution.

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

• Address project-specific resource challenges with the Project Manager.

• Escalate issues related to CRA performance and site compliance.

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

• Manage accountability and reconciliation of investigational products.

• Assume project management duties when a cross-functional PM is unavailable.

• Support business development and marketing initiatives.

• May negotiate site budgets and contracts with investigators.

• May review site visit reports and the execution of monitoring plans.

• May oversee clinical vendors.

• May conduct clinical data reviews and generate queries.

• May hold line management responsibilities.

• 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.

• A minimum of 7 years of clinical research experience or demonstrated competencies, particularly in clinical monitoring.

• Proficient in Microsoft Office Suite: Outlook, Word, Excel, and PowerPoint.

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

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

• Solid understanding of clinical management techniques and tools.

• Direct experience in a cross-functional work environment.

• Proven functional management experience, including effective delegation and fostering team cohesion.

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

• Extensive experience in pharmaceutical and/or device research.

• Proven ability in independent negotiation and conflict resolution strategies.

• Exceptional communication, interpersonal, organizational, presentation, verbal, and written skills.

• Strong attention to detail, customer service orientation, time management, negotiation, critical thinking, decision-making, analytical, and interpersonal skills.

• High integrity and the ability to maintain professional and ethical standards.

• Ability to lead and motivate a team towards excellence.

• Capacity to foster an environment that encourages employee ownership, productivity, and efficiency.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance coverage.

• Retirement savings benefits.

• Life insurance protection.

• Disability benefits.

• Parental leave provisions.

• Paid time off for sick leave and vacations.

• Equal Opportunity Employer.

• Reasonable accommodations provided during the application process.