Clinical Study Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Serve as a customer advocate throughout the entire clinical development project lifecycle.

• Support global program objectives, including site identification and assessment, patient/subject recruitment, KOL and Steering Committee development, and medical affairs assistance.

• Lead the creation of study-specific protocols, consent forms, monitoring plans, data management plans, advertising materials, and additional trial documents.

• Develop requests for proposals aimed at CROs, laboratories, data management groups, and other service providers.

• Assist with or take charge of the evaluation of vendors and study sites.

• Oversee CROs and other vendors involved in clinical studies.

• Develop, manage, and track clinical trial budgets, including payments to vendors and study sites.

• Proactively inform management about expected change orders and budget modifications.

• Support operational plans and monitor the ongoing progress of assigned studies.

• Collaborate with Medical, CMC, PRINT Teams, and Quality Assurance management to define study objectives and scope.

• Initiate and train sites on study protocols while ensuring adherence to regulatory guidelines.

• Coordinate study start-up activities, including agreements, IRBs, database readiness, monitoring strategies, QA audit plans, and Clinical Safety Review Teams.

• Manage materials necessary for clinical project execution, such as documents, forms, supplies, equipment, and investigational products.

• Review study data-system reports that cover data collection, source document verification, and query resolution.

• Assist with study data review during cleaning phases and escalate issues when necessary.

• Maintain program files and ensure ongoing updates to the Trial Master File and document completeness.

• Conduct regular quality checks on the TMF.

• Maintain program-specific tracking systems for efficient study management and monitoring.

• Ensure operational and regulatory integrity while participating in FDA or other regulatory authority inspections as required.

• Ensure that internal program team members receive proper training on study conduct.

• Act as a liaison between vendors and internal teams to relay program information and updates.

• Draft and distribute periodic study newsletters.

• Attend off-site meetings and conferences as necessary.

⛳️ Requirements

• Bachelor's degree with at least five years of experience in clinical research, including a minimum of two years in clinical project/study management.

• Experience in qualifying and managing external vendors, including CROs, call centers, and central laboratories.

• Proven experience managing clinical project team personnel.

• Background in leading program operational teams through study start-up, conduct, data management, and writing clinical study reports.

• Experience in reviewing and editing protocols and clinical study reports.

• Knowledge of Good Clinical Practices and relevant US regulations governing clinical research.

• Familiarity with the FDA submission process.

• Strong understanding of clinical trial budgeting and resource forecasting and management.

• Excellent organizational and communication skills, with experience interacting with physicians, IRB members, and FDA staff.

• Strong problem-solving and interpersonal skills.

• Ability to work independently while managing multiple timelines and deadlines.

• Capacity to exercise judgment and determine appropriate actions for problems of varying complexity.

• Ability to collaborate with remote teams and negotiate with external providers.

• Detail-oriented, highly organized, reliable, and precise.

• Self-motivated, adaptable, and capable of thriving in a matrix environment.

• Proficient in computer skills, including Microsoft programs and project management software.

• Strong verbal, written, and presentation abilities.

• Willingness to accommodate international and domestic travel up to 30% as required by the business.

🏝️ Benefits

• Competitive compensation package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Short-term disability (STD) coverage.

• Long-term disability (LTD) coverage.

• 401(k) Savings Retirement Plan.

• Employee Stock Purchase Plan (ESPP).

• Equal opportunity employment.

• Reasonable accommodations for qualified individuals with disabilities.