Clinical Trials Applications Specialist II

Actalent • Birmingham, AL

418d • $80,000 - $109,000 • Remote

About The Position

The Clinical Trials Applications Specialist II plays a crucial role in managing and supporting clinical trial processes through the Clinical Trial Management System (CTMS). This position involves collaborating with various stakeholders to ensure efficient and compliant management of clinical research activities, focusing on budget analysis, protocol interpretation, and quality assurance. The Specialist is responsible for maintaining relationships with operational research departments and providing excellent customer service while ensuring the effective implementation of CTMS builds.

Requirements

• Proficient Microsoft Office Suite skills (Word, Excel, and Outlook)
• Knowledge and understanding of Clinical Trial Management System builds
• Knowledge and understanding of clinical research protocols and budgets, including Medicare Coverage Analysis
• Motivated, organized, and able to function with minimal supervision
• Excellent interpersonal skills and a collaborative style necessary for interaction across departments
• Ability to work under pressure, meet fixed deadlines, and manage competing priorities
• Strong organizational and analytical skills
• Ethical and diplomatic with an ability to provide excellent customer service
• Knowledge of hospital policies and procedures regarding clinical research
• Knowledge of research, IT, or database operations
• Bachelor's degree in Healthcare, Business Administration, Finance, Computer Science, Information Technology, Nursing, or related field
• Two (2) years of full-time experience in building, amending, and maintaining research studies in CTMS or four (4) years of end-user utilization of the CTMS platform for research-related jobs
• Three (3) years of experience in healthcare, research, research administration, or related field

Nice To Haves

• General knowledge of Epic as it relates to CTMS interface and functions
• Advanced knowledge in Excel (V-Lookups, Pivot Tables, Index, etc.) and Power BI

Responsibilities

• Manage, coordinate, and monitor assigned projects and tasks in CTMS supporting efficient clinical research study implementation, processes, finances, and reporting.
• Review, interpret, and translate study documents such as protocols, informed consents, legal documents, and budgets to provide accurate and timely builds supporting clinical, financial, and compliance operations teams.
• Contribute to quality control and assurance functions to ensure that research projects are built and configured efficiently and accurately within the application to support financial recovery and tracking from sponsors.
• Develop and utilize standard tools, methodologies, and templates to aid successful application implementation.
• Collaborate with Information Technology to ensure study availability to end-users for timely activation of studies.
• Advise leadership on CTMS issues requiring escalation and propose recommendations to research leadership.
• Participate in the development, updates, and communication of training materials, policies, and procedures related to CTMS.
• Consult with stakeholders and partners to solve simple and complex problems related to CTMS builds, applying knowledge of applicable regulations, protocols, budgets, billing compliance, and finance requirements.
• Develop and maintain relationships with operational research departments and other internal/external stakeholders/collaborators.
• In coordination with management, orient, train, and provide guidance to new operational staff to achieve departmental goals and objectives.
• Follow, develop, and update established CTMS processes to ensure metrics and tracking, compliance, and document harmonization.
• Perform other administrative duties such as business requirement gathering, business process redesign, and application support as necessary.
• Update protocol information within the application as amendments occur to the protocol schedule of activities or budget.
• Interact with management and staff to provide useful information, guidance, and integrity to CTMS-related activities.
• Develop service level expectations and ensure these expectations are achieved.

Benefits

• Paid Days Off from Day One
• Student Loan Repayment Program
• Career Development
• Whole Person Wellbeing Resources
• Mental Health Resources and Support
• Pet Insurance
• Debt-free Education (Certifications and Degrees without out-of-pocket tuition expense)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees