Clinical Trial Manager/Senior Clinical Trial Manager

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $110.7k - $200.9k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 11%

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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 • Ensure studies comply with protocols, SOPs, ICH-GCP, and applicable regulatory requirements • Act as primary clinical point of contact with the client • Collaborate with the Project Manager on monthly invoicing and clinical budget variance management • Develop clinical documents, study forms, manuals, trackers, training materials, and CRF completion guidelines • Identify and develop training needs for CRAs and third-party vendors; present at Investigator and Study Kick-off meetings • Generate potential site lists and drive site feasibility • Identify enrollment risks and develop country recruitment/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 and review/approve IP 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 metrics from CTMS, DM query trends, and outstanding monitoring reports • Implement and manage the eTMF • Collaborate on CAPA development, implementation, and closure • Assist sites, staff, and CRAs with GCP audit preparation • Coordinate resourcing issues, escalate performance/compliance issues, and support data quality • Manage investigational product accountability and reconciliation • Assume project management responsibilities 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 plan execution • Manage clinical vendors as needed • Perform clinical data review and query generation as needed • May have line management responsibilities • Perform other duties assigned by management

🎯 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 and delegation • 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 • Advanced degree preferred • Experience with Radiopharmaceuticals and/or CAR-T studies preferred

🏖️ Benefits

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