Clinical Trials Lead Consultant - SME

IBM Computing; Huntsville (AL); Remote; USD 80,000 - 120,000; Full time

Job summary

Join an innovative firm as a Clinical Trials Lead Consultant, where you'll play a pivotal role in advancing oncology care for veterans. This position involves managing research studies, ensuring compliance with regulations, and collaborating with stakeholders to achieve impactful results. You will leverage your expertise in clinical trials management and oncology to drive initiatives that improve patient care. With opportunities for professional growth and a culture that values curiosity and collaboration, this role is perfect for those passionate about making a difference in clinical research. Embrace the chance to lead groundbreaking projects that shape the future of healthcare.

Qualifications

• 5+ years experience in clinical trials management or research coordination.
• Strong knowledge of GCP and HIPAA regulations.
• Exceptional organizational and problem-solving skills.

Responsibilities

• Manage initiation of research studies and prepare IRB applications.
• Identify and screen eligible study participants for trials.
• Create and implement study execution workflows and SOPs.

Skills

Clinical Trials Management

Good Clinical Practices (GCP)

HIPAA Regulations

Project Management

Data Management

Stakeholder Communication

Problem Solving

Oncology Knowledge

Education

Advanced Degree in Clinical Trials or Related Field

Tools

Telehealth Technologies

Job description

Introduction

A career in IBM Consulting is rooted by long-term relationships and close collaboration with clients across the globe.

You'll work with visionaries across multiple industries to improve the hybrid cloud and AI journey for the most innovative and valuable companies in

the world. Your ability to accelerate impact and make meaningful change for your clients is enabled by our strategic partner ecosystem and our

robust technology platforms across the IBM portfolio; including Software and Red Hat.

Curiosity and a constant quest for knowledge serve as the foundation to success in IBM Consulting. In your role, you'll be encouraged to challenge

the norm, investigate ideas outside of your role, and come up with creative solutions resulting in ground breaking impact for a wide network of

clients. Our culture of evolution and empathy centers on long-term career growth and development opportunities in an environment that embraces

your unique skills and experience.

Your role and responsibilities

We are seeking a Clinical Trials Lead Consultant to support the VA National Oncology Program by providing subject matter expertise and driving clinical trial initiatives on a key contract. This role plays a critical part in ensuring the successful execution of research studies and advancing oncology care for veterans.

Key Responsibilities:

• Study Preparation: Manage the initiation of research studies, including contracting and study setup. Prepare and submit Institutional Review Board (IRB) applications and other relevant documentation.

• Patient Screening and Recruitment: Identify and screen eligible study participants, and develop recruitment materials to support enrollment efforts.

• Data Management and Compliance: Assist with study data collection and ensure proper documentation in adherence to Good Clinical Practices (GCP) and HIPAA regulations.

• Workflow and Process Development: Create and implement study execution workflows and Standard Operating Procedures (SOPs). Identify process gaps within VA operations and documentation and propose solutions for improvement.

• Stakeholder Collaboration: Facilitate communication with stakeholders, provide regular progress reports, and ensure alignment across teams to achieve study objectives.

Qualifications:

• Proven experience in clinical trials management or research coordination.

• Strong knowledge of GCP and HIPAA regulations.

• Experience with IRB submissions and contracting processes.

• Exceptional organizational and problem-solving skills to identify and address gaps in workflows and documentation.

• Effective communication and collaboration skills to engage stakeholders and report on progress.

This role offers the opportunity to contribute to impactful oncology research while improving processes and workflows within the VA system. If you are passionate about clinical research and thrive in a leadership role, we encourage you to apply!

This Job can be performed from anywhere in the US

Required technical and professional expertise

Clinical Trials Lead Consultant - SME for this requirement must demonstrate the following:

• Experience as a clinical trials physician or nurse (advanced degree candidates considered)

• Experience conducting oncology or related clinical trials (5 years minimum)

• Experience serving as an expert for a research team

• Experience working on multi-institutional or national level projects

• Experience working virtually or leading projects using innovative technology i.e. telehealth.

• Experience in clinical research including regulatory, data management, coordination, fiscal, project management

• Comprehensive understanding of oncology or clinical continuum of care

• Ability to obtain and maintain a Federal security clearance with the US government

Preferred technical and professional experience

• Highly motivated, with clear evidence of drive and significant achievements

• Drive to overcome challenging or difficult obstacles and look for ways to improve results

• Ability to handle multiple tasks concurrently and meet deadlines, while maintaining focus in an environment with conflicting demands

IBM is committed to creating a diverse environment and is proud to be an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity or expression, sexual orientation, national origin, caste, genetics, pregnancy, disability, neurodivergence, age, veteran status, or other characteristics. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.