Clinical Trial Manager/Senior Clinical Trial Manager

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Serve as the clinical trial lead responsible for planning, conduct, and operational oversight of clinical studies • Act as the primary clinical point of contact with the client • Collaborate with the Project Manager on monthly invoicing and clinical budget variance management • Develop clinical study documents, plans, forms, manuals, trackers, slides, and training materials • Identify training needs for CRAs and third-party vendors and present training at investigator and study kick-off meetings • Generate potential site lists and drive site feasibility • Identify enrollment risks and develop country recruitment and retention strategies • Establish communication and working relationships with investigators and study teams throughout feasibility, start-up, enrollment, maintenance, and closeout • Lead internal clinical team meetings and set expectations for CRAs and CTAs • Address CRA and site questions and maintain the FAQ log • Support investigator meeting planning and conduct • Review or approve investigational product release packages • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies to meet timelines and quality requirements • Generate and use 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 and ensure timely closure • Assist sites, internal staff, and CRAs with GCP audit preparation • Address project-specific resourcing issues with the Project Manager • Escalate CRA performance and site compliance issues • Collaborate with data management and CRAs to ensure data quality and cleaning timelines • Manage investigational product accountability and reconciliation • Assume project management responsibilities when a cross-functional PM is not assigned • Support business development and marketing activities • May negotiate site budgets and investigator contracts • May review site visit reports and monitoring-plan execution • May manage clinical vendors • May perform clinical data review and query generation • May have line management responsibilities • Perform other duties assigned by management

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in a science or health-related field • Minimum 7 years of clinical research experience or proven competencies, with significant clinical monitoring experience • Experience with Microsoft Office products: Outlook, Word, Excel, and PowerPoint • Ability to travel domestically and internationally, including overnight stays • Mastery of ICH-GCP, relevant Precision SOPs, and regulatory guidance • Working knowledge of clinical management techniques and tools • Direct experience in a cross-functional environment • Proven functional management experience, including delegation and fostering cohesive team dynamics • Proven experience in planning, risk management, and change management • In-depth proven experience in pharmaceutical and/or device research • Demonstrated successful independent negotiation and conflict-management strategies • Excellent communication, interpersonal, organizational, presentation, verbal, and written communication skills • Strong attention to detail, customer-service demeanor, time management, negotiation, critical-thinking, decision-making, analytical, and interpersonal skills • High integrity and ability to uphold professional and ethical standards • Ability to lead and inspire excellence within a team • Ability to create an environment that promotes employee ownership, productivity, and efficiency

🏖️ Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation • Equal Opportunity Employer • Reasonable accommodation during the application process