Clinical Trial Manager – Senior

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.

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

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

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

• Identify training requirements for CRAs and third-party vendors and deliver training during Investigator and Study Kick-off meetings.

• Generate potential site lists and facilitate the site feasibility process.

• Recognize enrollment risks and formulate country-specific recruitment and retention strategies.

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

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

• Address questions from CRAs and sites while maintaining FAQ logs.

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

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

• Develop clinical monitoring strategies and utilize metrics to ensure adherence to timelines, quality, and study compliance.

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

• Collaborate on the development, implementation, and timely closure of CAPAs.

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

• Coordinate project-specific resource issues and escalate CRA performance or site compliance concerns.

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

• Manage the accountability and reconciliation of investigational products.

• Take on project management responsibilities when a cross-functional Project Manager is not designated.

• Support business development and marketing initiatives.

• Potentially negotiate site budgets and contracts with investigators.

• Possibly review site visit reports, oversee clinical vendors, conduct clinical data reviews, and supervise staff.

⛳️ 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, including substantial clinical monitoring experience.

• An advanced degree is preferred.

• Proficiency in Microsoft Office products: Outlook, Word, Excel, and PowerPoint.

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

• Mastery of ICH-GCP, relevant Precision Standard Operating Procedures, and regulatory guidance.

• Familiarity with clinical management techniques and tools.

• Direct experience in a cross-functional work environment.

• Experience in functional management and delegation.

• Background in planning, risk management, and change management.

• Extensive proven experience in pharmaceutical and/or device research.

• Successful experience in independent negotiation and conflict resolution.

• 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 abilities.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.