Clinical Trial Manager – Senior Clinical Trial Manager

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $110.7k - $200.9k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 oversight of the operational portion of clinical studies • Ensure clinical studies comply with protocols, SOPs, ICH-GCP, and applicable regulatory requirements • Act as the primary clinical point of contact with the client • Collaborate with the PM on monthly invoicing and clinical budget variance management • Develop clinical documents, study 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 site feasibility • Develop country recruitment and retention strategies • Coordinate feasibility, site start-up, enrollment, maintenance, and close-out procedures • Lead internal clinical team meetings and set expectations for CRAs and CTAs • Address CRA and site questions and maintain FAQ logs • Support investigator meetings • Review or approve investigational product release packages • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies and track study timelines and quality deliverables • Generate and use metric reporting, including CTMS, DM query trends, and outstanding monitoring reports • Implement and manage the eTMF • Develop and implement CAPA plans with PM, CRAs, and QA • Assist sites, staff, and CRAs with GCP audit preparation • 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 responsibility when a cross-functional PM is not assigned • Support business development and marketing activities • Negotiate site budgets and investigator contracts as needed • Review site visit reports and ensure monitoring follows the monitoring plan • Manage clinical vendors as needed • Perform clinical data review and query generation as needed • May have line management responsibilities

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field • Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) • Excellent communication and interpersonal skills to effectively interface with others in a team setting • Excellent organizational skills, attention to detail, and a customer service demeanor • Ability to travel domestically and internationally including overnight stays • Mastery knowledge 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 • Proven experience in functional management, planning, risk management, and change management • In-depth proven experience in pharmaceutical and/or device research required • Demonstrated successful independent negotiation and conflict management strategies • Candidates must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

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