Remote Clinical Manager - Case Operations

Job Overview

We are seeking a highly skilled Clinical Case Manager to join our dynamic team in a fully remote position. This role is ideal for professionals who possess exceptional organizational skills paired with the adaptability to address both strategic objectives and everyday details of clinical operations.

Key Responsibilities

• Overseeing the management of clinical operations for industry-sponsored clinical trials, focusing on Endpoint and Specialty Services.
• Defining, monitoring, and ensuring adherence to project scope, timelines, and deliverables throughout the trial lifecycle.
• Identifying team training requirements and ensuring all training is completed and documented effectively.
• Managing trial-related functions to guarantee the quality of services and project deliverables.
• Approving vendor payments and providing expert guidance on critical project documentation, including protocols and project management plans.
• Leading multidisciplinary project teams, fostering effective communication and collaboration during meetings.
• Providing project updates and reports to sponsors according to contractual obligations.
• Planning and conducting investigator meetings as necessary.
• Collaborating with the Business Development team on budget proposals and change orders.
• Ensuring alignment among all stakeholders regarding project scope and addressing any potential timeline or budget impacts.
• Overseeing the management of the Trial Master File (TMF), both electronic and paper-based.
• Ensuring compliance with local, federal, and international regulations, policies, and standard operating procedures (SOPs).
• Monitoring project deliverables related to Endpoint and Specialty Services.
• Managing the Serious Adverse Event (SAE) process and confirming the execution of safety plans.
• Overseeing data entry, cleaning, and management of study databases.
• Providing constructive feedback to study sites regarding quality issues and document accuracy.
• Offering operational support for biostatistics and programming deliverables.
  
  

Required Skills

• Nursing or BA/BS degree in a scientific discipline (or equivalent experience).
• A minimum of 4 years in a clinical research environment, with at least 2 years in project or operations management.
• Proven capability to manage every aspect of clinical trials with minimal supervision.
• Comprehensive knowledge of Good Clinical Practice (GCP), FDA, and ICH regulations.
• Proficiency in Microsoft Office Suite (Outlook, Word, Excel).
• Exceptional communication, organizational, and attention-to-detail skills.
• Demonstrated experience in leading multidisciplinary teams and promoting collaboration.
• Strong problem-solving and conflict resolution abilities.
• Willingness to travel 20-25% of the time.
  
  

Qualifications

• At least 4 years of experience in a clinical research setting.
• 2 years of experience in project or operations management.
  
  

Career Growth Opportunities

This position offers substantial exposure to clinical operations management, enabling you to enhance your leadership skills while playing a crucial role in diverse industry-sponsored clinical trials.

Company Culture And Values

We prioritize a collaborative environment where team contributions are valued and recognized, fostering a culture of mutual respect and commitment to excellence.

Compensation And Benefits

• Targeted Compensation: \(72,000 - \)95,000 annually.
• Comprehensive benefits package including medical, dental, vision, and life insurance.
• Generous paid time off and 11 paid holidays.
• 15-25 vacation days depending on years of service.
• Matching 401(k) plan.
• Access to an in-suite exercise and relaxation room.
• Flexible and remote work arrangements.
• Monthly team-building events.
  
  

Join us in making a meaningful impact in clinical trials while advancing your career in a supportive and professional environment.

Employment Type: Full-Time