Clinical Trial Manager – Senior

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $110.7k - $200.9k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Serve as the clinical trial lead responsible for planning, conduct, and oversight of the operational portion 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 study-related clinical documents, plans, forms, manuals, guidelines, 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 the site feasibility process • Identify enrollment risks and develop country recruitment and retention strategies • Manage communication and relationships with investigators and study teams throughout feasibility, site 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 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 use metrics to ensure timelines, quality, and study compliance • Implement and manage the eTMF • Collaborate on CAPA development, implementation, and timely closure • Assist sites, internal staff, and CRAs with GCP audit preparation • Coordinate project-specific resourcing issues and escalate CRA performance or 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 Project Manager is not assigned • Support business development and marketing activities • Potentially negotiate site budgets and investigator contracts • Potentially review site visit reports, manage clinical vendors, perform clinical data review, and supervise staff

🎯 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, including significant clinical monitoring experience • Advanced degree preferred • 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 work experience in a cross-functional environment • Experience in functional management and delegation • Experience in planning, risk management, and change management • In-depth proven experience in pharmaceutical and/or device research • Successful independent negotiation and conflict management experience • Excellent communication, interpersonal, organizational, presentation, verbal, and written communication skills • Strong attention to detail, customer service orientation, time management, negotiation, critical thinking, decision-making, analytical, and interpersonal skills

🏖️ Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation